Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 73
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
$message = 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 73
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
$stackFrame = (int) 1
$trace = [
	(int) 0 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ServerRequest.php',
		'line' => (int) 2421,
		'function' => 'deprecationWarning',
		'args' => [
			(int) 0 => 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead.'
		]
	],
	(int) 1 => [
		'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php',
		'line' => (int) 73,
		'function' => 'offsetGet',
		'class' => 'Cake\Http\ServerRequest',
		'object' => object(Cake\Http\ServerRequest) {},
		'type' => '->',
		'args' => [
			(int) 0 => 'catslug'
		]
	],
	(int) 2 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Controller/Controller.php',
		'line' => (int) 610,
		'function' => 'printArticle',
		'class' => 'App\Controller\ArtileDetailController',
		'object' => object(App\Controller\ArtileDetailController) {},
		'type' => '->',
		'args' => []
	],
	(int) 3 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php',
		'line' => (int) 120,
		'function' => 'invokeAction',
		'class' => 'Cake\Controller\Controller',
		'object' => object(App\Controller\ArtileDetailController) {},
		'type' => '->',
		'args' => []
	],
	(int) 4 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php',
		'line' => (int) 94,
		'function' => '_invoke',
		'class' => 'Cake\Http\ActionDispatcher',
		'object' => object(Cake\Http\ActionDispatcher) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(App\Controller\ArtileDetailController) {}
		]
	],
	(int) 5 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/BaseApplication.php',
		'line' => (int) 235,
		'function' => 'dispatch',
		'class' => 'Cake\Http\ActionDispatcher',
		'object' => object(Cake\Http\ActionDispatcher) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 6 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Http\BaseApplication',
		'object' => object(App\Application) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 7 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/RoutingMiddleware.php',
		'line' => (int) 162,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 8 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Routing\Middleware\RoutingMiddleware',
		'object' => object(Cake\Routing\Middleware\RoutingMiddleware) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 9 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/AssetMiddleware.php',
		'line' => (int) 88,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 10 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Routing\Middleware\AssetMiddleware',
		'object' => object(Cake\Routing\Middleware\AssetMiddleware) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 11 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Middleware/ErrorHandlerMiddleware.php',
		'line' => (int) 96,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 12 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Error\Middleware\ErrorHandlerMiddleware',
		'object' => object(Cake\Error\Middleware\ErrorHandlerMiddleware) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 13 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 51,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 14 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Server.php',
		'line' => (int) 98,
		'function' => 'run',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\MiddlewareQueue) {},
			(int) 1 => object(Cake\Http\ServerRequest) {},
			(int) 2 => object(Cake\Http\Response) {}
		]
	],
	(int) 15 => [
		'file' => '/home/brlfuser/public_html/webroot/index.php',
		'line' => (int) 39,
		'function' => 'run',
		'class' => 'Cake\Http\Server',
		'object' => object(Cake\Http\Server) {},
		'type' => '->',
		'args' => []
	]
]
$frame = [
	'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php',
	'line' => (int) 73,
	'function' => 'offsetGet',
	'class' => 'Cake\Http\ServerRequest',
	'object' => object(Cake\Http\ServerRequest) {
		trustProxy => false
		[protected] params => [
			[maximum depth reached]
		]
		[protected] data => [[maximum depth reached]]
		[protected] query => [[maximum depth reached]]
		[protected] cookies => [
			[maximum depth reached]
		]
		[protected] _environment => [
			[maximum depth reached]
		]
		[protected] url => 'latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342/print'
		[protected] base => ''
		[protected] webroot => '/'
		[protected] here => '/latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342/print'
		[protected] trustedProxies => [[maximum depth reached]]
		[protected] _input => null
		[protected] _detectors => [
			[maximum depth reached]
		]
		[protected] _detectorCache => [
			[maximum depth reached]
		]
		[protected] stream => object(Zend\Diactoros\PhpInputStream) {}
		[protected] uri => object(Zend\Diactoros\Uri) {}
		[protected] session => object(Cake\Http\Session) {}
		[protected] attributes => [[maximum depth reached]]
		[protected] emulatedAttributes => [
			[maximum depth reached]
		]
		[protected] uploadedFiles => [[maximum depth reached]]
		[protected] protocol => null
		[protected] requestTarget => null
		[private] deprecatedProperties => [
			[maximum depth reached]
		]
	},
	'type' => '->',
	'args' => [
		(int) 0 => 'catslug'
	]
]
deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 73
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 74
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
$message = 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 74
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
$stackFrame = (int) 1
$trace = [
	(int) 0 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ServerRequest.php',
		'line' => (int) 2421,
		'function' => 'deprecationWarning',
		'args' => [
			(int) 0 => 'The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead.'
		]
	],
	(int) 1 => [
		'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php',
		'line' => (int) 74,
		'function' => 'offsetGet',
		'class' => 'Cake\Http\ServerRequest',
		'object' => object(Cake\Http\ServerRequest) {},
		'type' => '->',
		'args' => [
			(int) 0 => 'artileslug'
		]
	],
	(int) 2 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Controller/Controller.php',
		'line' => (int) 610,
		'function' => 'printArticle',
		'class' => 'App\Controller\ArtileDetailController',
		'object' => object(App\Controller\ArtileDetailController) {},
		'type' => '->',
		'args' => []
	],
	(int) 3 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php',
		'line' => (int) 120,
		'function' => 'invokeAction',
		'class' => 'Cake\Controller\Controller',
		'object' => object(App\Controller\ArtileDetailController) {},
		'type' => '->',
		'args' => []
	],
	(int) 4 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/ActionDispatcher.php',
		'line' => (int) 94,
		'function' => '_invoke',
		'class' => 'Cake\Http\ActionDispatcher',
		'object' => object(Cake\Http\ActionDispatcher) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(App\Controller\ArtileDetailController) {}
		]
	],
	(int) 5 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/BaseApplication.php',
		'line' => (int) 235,
		'function' => 'dispatch',
		'class' => 'Cake\Http\ActionDispatcher',
		'object' => object(Cake\Http\ActionDispatcher) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 6 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Http\BaseApplication',
		'object' => object(App\Application) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 7 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/RoutingMiddleware.php',
		'line' => (int) 162,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 8 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Routing\Middleware\RoutingMiddleware',
		'object' => object(Cake\Routing\Middleware\RoutingMiddleware) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 9 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Routing/Middleware/AssetMiddleware.php',
		'line' => (int) 88,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 10 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Routing\Middleware\AssetMiddleware',
		'object' => object(Cake\Routing\Middleware\AssetMiddleware) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 11 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Middleware/ErrorHandlerMiddleware.php',
		'line' => (int) 96,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 12 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 65,
		'function' => '__invoke',
		'class' => 'Cake\Error\Middleware\ErrorHandlerMiddleware',
		'object' => object(Cake\Error\Middleware\ErrorHandlerMiddleware) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {},
			(int) 2 => object(Cake\Http\Runner) {}
		]
	],
	(int) 13 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Runner.php',
		'line' => (int) 51,
		'function' => '__invoke',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\ServerRequest) {},
			(int) 1 => object(Cake\Http\Response) {}
		]
	],
	(int) 14 => [
		'file' => '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Http/Server.php',
		'line' => (int) 98,
		'function' => 'run',
		'class' => 'Cake\Http\Runner',
		'object' => object(Cake\Http\Runner) {},
		'type' => '->',
		'args' => [
			(int) 0 => object(Cake\Http\MiddlewareQueue) {},
			(int) 1 => object(Cake\Http\ServerRequest) {},
			(int) 2 => object(Cake\Http\Response) {}
		]
	],
	(int) 15 => [
		'file' => '/home/brlfuser/public_html/webroot/index.php',
		'line' => (int) 39,
		'function' => 'run',
		'class' => 'Cake\Http\Server',
		'object' => object(Cake\Http\Server) {},
		'type' => '->',
		'args' => []
	]
]
$frame = [
	'file' => '/home/brlfuser/public_html/src/Controller/ArtileDetailController.php',
	'line' => (int) 74,
	'function' => 'offsetGet',
	'class' => 'Cake\Http\ServerRequest',
	'object' => object(Cake\Http\ServerRequest) {
		trustProxy => false
		[protected] params => [
			[maximum depth reached]
		]
		[protected] data => [[maximum depth reached]]
		[protected] query => [[maximum depth reached]]
		[protected] cookies => [
			[maximum depth reached]
		]
		[protected] _environment => [
			[maximum depth reached]
		]
		[protected] url => 'latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342/print'
		[protected] base => ''
		[protected] webroot => '/'
		[protected] here => '/latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342/print'
		[protected] trustedProxies => [[maximum depth reached]]
		[protected] _input => null
		[protected] _detectors => [
			[maximum depth reached]
		]
		[protected] _detectorCache => [
			[maximum depth reached]
		]
		[protected] stream => object(Zend\Diactoros\PhpInputStream) {}
		[protected] uri => object(Zend\Diactoros\Uri) {}
		[protected] session => object(Cake\Http\Session) {}
		[protected] attributes => [[maximum depth reached]]
		[protected] emulatedAttributes => [
			[maximum depth reached]
		]
		[protected] uploadedFiles => [[maximum depth reached]]
		[protected] protocol => null
		[protected] requestTarget => null
		[private] deprecatedProperties => [
			[maximum depth reached]
		]
	},
	'type' => '->',
	'args' => [
		(int) 0 => 'artileslug'
	]
]
deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 74
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

                trigger_error($message, E_USER_WARNING);

            } else {
$response = object(Cake\Http\Response) {

	'status' => (int) 200,
	'contentType' => 'text/html',
	'headers' => [
		'Content-Type' => [
			[maximum depth reached]
		]
	],
	'file' => null,
	'fileRange' => [],
	'cookies' => object(Cake\Http\Cookie\CookieCollection) {},
	'cacheDirectives' => [],
	'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
        "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
    <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-trace').style.display = (document.getElementById('cakeErr67f71f0467a3f-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f71f0467a3f-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-code').style.display = (document.getElementById('cakeErr67f71f0467a3f-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-context').style.display = (document.getElementById('cakeErr67f71f0467a3f-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f71f0467a3f-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700">&lt;</span><span style="color: #0000BB">head</span><span style="color: #007700">&gt;
</span></span></code>
<span class="code-highlight"><code><span style="color: #000000">&nbsp;&nbsp;&nbsp;&nbsp;&lt;link&nbsp;rel="canonical"&nbsp;href="<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">);&nbsp;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">category</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">slug</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>/<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">seo_url</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>.html"/&gt;
</span></code></span>
<code><span style="color: #000000"><span style="color: #0000BB">&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="color: #007700">&lt;</span><span style="color: #0000BB">meta&nbsp;http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type"&nbsp;</span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html;&nbsp;charset=utf-8"</span><span style="color: #007700">/&gt;
</span></span></code></pre><pre id="cakeErr67f71f0467a3f-context" class="cake-context" style="display: none;">$viewFile = &#039;/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp&#039;
$dataForView = [
	&#039;article_current&#039; =&gt; object(App\Model\Entity\Article) {

		&#039;id&#039; =&gt; (int) 21197,
		&#039;title&#039; =&gt; &#039;US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
		&#039;subheading&#039; =&gt; &#039;&#039;,
		&#039;description&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;
-The Times of India
&lt;/div&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;br /&gt;
&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. 
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.
&lt;/p&gt;&#039;,
		&#039;credit_writer&#039; =&gt; &#039;The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms&#039;,
		&#039;article_img&#039; =&gt; &#039;&#039;,
		&#039;article_img_thumb&#039; =&gt; &#039;&#039;,
		&#039;status&#039; =&gt; (int) 1,
		&#039;show_on_home&#039; =&gt; (int) 1,
		&#039;lang&#039; =&gt; &#039;EN&#039;,
		&#039;category_id&#039; =&gt; (int) 16,
		&#039;tag_keyword&#039; =&gt; &#039;&#039;,
		&#039;seo_url&#039; =&gt; &#039;us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342&#039;,
		&#039;meta_title&#039; =&gt; null,
		&#039;meta_keywords&#039; =&gt; null,
		&#039;meta_description&#039; =&gt; null,
		&#039;noindex&#039; =&gt; (int) 0,
		&#039;publish_date&#039; =&gt; object(Cake\I18n\FrozenDate) {},
		&#039;most_visit_section_id&#039; =&gt; null,
		&#039;article_big_img&#039; =&gt; null,
		&#039;liveid&#039; =&gt; (int) 21342,
		&#039;created&#039; =&gt; object(Cake\I18n\FrozenTime) {},
		&#039;modified&#039; =&gt; object(Cake\I18n\FrozenTime) {},
		&#039;edate&#039; =&gt; &#039;&#039;,
		&#039;tags&#039; =&gt; [
			[maximum depth reached]
		],
		&#039;category&#039; =&gt; object(App\Model\Entity\Category) {},
		&#039;[new]&#039; =&gt; false,
		&#039;[accessible]&#039; =&gt; [
			[maximum depth reached]
		],
		&#039;[dirty]&#039; =&gt; [[maximum depth reached]],
		&#039;[original]&#039; =&gt; [[maximum depth reached]],
		&#039;[virtual]&#039; =&gt; [[maximum depth reached]],
		&#039;[hasErrors]&#039; =&gt; false,
		&#039;[errors]&#039; =&gt; [[maximum depth reached]],
		&#039;[invalid]&#039; =&gt; [[maximum depth reached]],
		&#039;[repository]&#039; =&gt; &#039;Articles&#039;
	
	},
	&#039;articleid&#039; =&gt; (int) 21197,
	&#039;metaTitle&#039; =&gt; &#039;LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
	&#039;metaKeywords&#039; =&gt; &#039;medicines,generic drugs,Health&#039;,
	&#039;metaDesc&#039; =&gt; &#039;
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...&#039;,
	&#039;disp&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;-The Times of India&lt;/div&gt;&lt;p align=&quot;justify&quot;&gt;&lt;br /&gt;&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. &lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.&lt;/p&gt;&#039;,
	&#039;lang&#039; =&gt; &#039;English&#039;,
	&#039;SITE_URL&#039; =&gt; &#039;https://im4change.in/&#039;,
	&#039;site_title&#039; =&gt; &#039;im4change&#039;,
	&#039;adminprix&#039; =&gt; &#039;admin&#039;
]
$article_current = object(App\Model\Entity\Article) {

	&#039;id&#039; =&gt; (int) 21197,
	&#039;title&#039; =&gt; &#039;US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
	&#039;subheading&#039; =&gt; &#039;&#039;,
	&#039;description&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;
-The Times of India
&lt;/div&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;br /&gt;
&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. 
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.
&lt;/p&gt;&#039;,
	&#039;credit_writer&#039; =&gt; &#039;The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms&#039;,
	&#039;article_img&#039; =&gt; &#039;&#039;,
	&#039;article_img_thumb&#039; =&gt; &#039;&#039;,
	&#039;status&#039; =&gt; (int) 1,
	&#039;show_on_home&#039; =&gt; (int) 1,
	&#039;lang&#039; =&gt; &#039;EN&#039;,
	&#039;category_id&#039; =&gt; (int) 16,
	&#039;tag_keyword&#039; =&gt; &#039;&#039;,
	&#039;seo_url&#039; =&gt; &#039;us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342&#039;,
	&#039;meta_title&#039; =&gt; null,
	&#039;meta_keywords&#039; =&gt; null,
	&#039;meta_description&#039; =&gt; null,
	&#039;noindex&#039; =&gt; (int) 0,
	&#039;publish_date&#039; =&gt; object(Cake\I18n\FrozenDate) {},
	&#039;most_visit_section_id&#039; =&gt; null,
	&#039;article_big_img&#039; =&gt; null,
	&#039;liveid&#039; =&gt; (int) 21342,
	&#039;created&#039; =&gt; object(Cake\I18n\FrozenTime) {},
	&#039;modified&#039; =&gt; object(Cake\I18n\FrozenTime) {},
	&#039;edate&#039; =&gt; &#039;&#039;,
	&#039;tags&#039; =&gt; [
		(int) 0 =&gt; object(Cake\ORM\Entity) {},
		(int) 1 =&gt; object(Cake\ORM\Entity) {},
		(int) 2 =&gt; object(Cake\ORM\Entity) {}
	],
	&#039;category&#039; =&gt; object(App\Model\Entity\Category) {},
	&#039;[new]&#039; =&gt; false,
	&#039;[accessible]&#039; =&gt; [
		&#039;*&#039; =&gt; true,
		&#039;id&#039; =&gt; false
	],
	&#039;[dirty]&#039; =&gt; [],
	&#039;[original]&#039; =&gt; [],
	&#039;[virtual]&#039; =&gt; [],
	&#039;[hasErrors]&#039; =&gt; false,
	&#039;[errors]&#039; =&gt; [],
	&#039;[invalid]&#039; =&gt; [],
	&#039;[repository]&#039; =&gt; &#039;Articles&#039;

}
$articleid = (int) 21197
$metaTitle = &#039;LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;
$metaKeywords = &#039;medicines,generic drugs,Health&#039;
$metaDesc = &#039;
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...&#039;
$disp = &#039;&lt;div align=&quot;justify&quot;&gt;-The Times of India&lt;/div&gt;&lt;p align=&quot;justify&quot;&gt;&lt;br /&gt;&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. &lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.&lt;/p&gt;&#039;
$lang = &#039;English&#039;
$SITE_URL = &#039;https://im4change.in/&#039;
$site_title = &#039;im4change&#039;
$adminprix = &#039;admin&#039;</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342.html"/>
    <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
    <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css"
          media="all"/>
    <title>LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli | Im4change.org</title>
    <meta name="description" content="
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs..."/>
    <script src="https://im4change.in/js/jquery-1.10.2.js"></script>
    <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script>
    <script language="javascript" type="text/javascript">

        $(document).ready(function () {
            var img = $("img")[0]; // Get my img elem
            var pic_real_width, pic_real_height;
            $("<img/>") // Make in memory copy of image to avoid css issues
                .attr("src", $(img).attr("src"))
                .load(function () {
                    pic_real_width = this.width;   // Note: $(this).width() will not
                    pic_real_height = this.height; // work for in memory images.
                });
        });
    </script>
    <style type="text/css">
        @media screen {
            div.divFooter {
                display: block;
            }
        }

        @media print {
            .printbutton {
                display: none !important;
            }
        }
    </style>
</head>
<body>
<table cellpadding="0" cellspacing="0" border="0" width="98%" align="center">
    <tr>
        <td class="top_bg">
            <div class="divFooter">
                <img src="https://im4change.in/images/logo1.jpg" height="59" border="0"
                     alt="Resource centre on India's rural distress" style="padding-top:14px;"/>
            </div>

        </td>
    </tr>
    <tr>
        <td id="topspace">&nbsp;</td>
    </tr>

    <tr id="topspace">
        <td>&nbsp;</td>
    </tr>
    <tr>
        <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton">
            <form><input type="button" value=" Print this page "
                         onclick="window.print();return false;"/></form>
        </td>
    </tr>

    <tr>
        <td width="100%">
            <h1 class="news_headlines" style="font-style:normal">
                <strong>US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli</strong></h1>
        </td>
    </tr>
    <tr>
        <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3">
                <div align="justify">-The Times of India</div><p align="justify"><br /><em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.</p><p align="justify">Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.</p><p align="justify">&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. </p><p align="justify">It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.</p><p align="justify">&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;</p><p align="justify">At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.</p><p align="justify"><em>More Indian pharma cos come under FDA scrutiny</em></p><p align="justify">Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.</p><p align="justify">Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.</p><p align="justify">While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.</p>               </font>
        </td>
    </tr>
    <tr>
        <td>&nbsp;</td>
    </tr>

    <tr>
        <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;">
            <form><input type="button" value=" Print this page "
                         onclick="window.print();return false;"/></form>
        </td>
    </tr>
</table></body>
</html>'

}
$maxBufferLength = (int) 8192
$file = '/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php'
$line = (int) 853
$message = 'Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853'
Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 48
Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141
[main] - ROOT/webroot/index.php, line 39

Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 148]
Code Context
            $response->getStatusCode(),

            ($reasonPhrase ? ' ' . $reasonPhrase : '')

        ));
$response = object(Cake\Http\Response) {

	'status' => (int) 200,
	'contentType' => 'text/html',
	'headers' => [
		'Content-Type' => [
			[maximum depth reached]
		]
	],
	'file' => null,
	'fileRange' => [],
	'cookies' => object(Cake\Http\Cookie\CookieCollection) {},
	'cacheDirectives' => [],
	'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
        "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
    <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-trace').style.display = (document.getElementById('cakeErr67f71f0467a3f-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f71f0467a3f-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-code').style.display = (document.getElementById('cakeErr67f71f0467a3f-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-context').style.display = (document.getElementById('cakeErr67f71f0467a3f-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f71f0467a3f-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700">&lt;</span><span style="color: #0000BB">head</span><span style="color: #007700">&gt;
</span></span></code>
<span class="code-highlight"><code><span style="color: #000000">&nbsp;&nbsp;&nbsp;&nbsp;&lt;link&nbsp;rel="canonical"&nbsp;href="<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">);&nbsp;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">category</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">slug</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>/<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">seo_url</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>.html"/&gt;
</span></code></span>
<code><span style="color: #000000"><span style="color: #0000BB">&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="color: #007700">&lt;</span><span style="color: #0000BB">meta&nbsp;http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type"&nbsp;</span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html;&nbsp;charset=utf-8"</span><span style="color: #007700">/&gt;
</span></span></code></pre><pre id="cakeErr67f71f0467a3f-context" class="cake-context" style="display: none;">$viewFile = &#039;/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp&#039;
$dataForView = [
	&#039;article_current&#039; =&gt; object(App\Model\Entity\Article) {

		&#039;id&#039; =&gt; (int) 21197,
		&#039;title&#039; =&gt; &#039;US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
		&#039;subheading&#039; =&gt; &#039;&#039;,
		&#039;description&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;
-The Times of India
&lt;/div&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;br /&gt;
&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. 
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.
&lt;/p&gt;&#039;,
		&#039;credit_writer&#039; =&gt; &#039;The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms&#039;,
		&#039;article_img&#039; =&gt; &#039;&#039;,
		&#039;article_img_thumb&#039; =&gt; &#039;&#039;,
		&#039;status&#039; =&gt; (int) 1,
		&#039;show_on_home&#039; =&gt; (int) 1,
		&#039;lang&#039; =&gt; &#039;EN&#039;,
		&#039;category_id&#039; =&gt; (int) 16,
		&#039;tag_keyword&#039; =&gt; &#039;&#039;,
		&#039;seo_url&#039; =&gt; &#039;us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342&#039;,
		&#039;meta_title&#039; =&gt; null,
		&#039;meta_keywords&#039; =&gt; null,
		&#039;meta_description&#039; =&gt; null,
		&#039;noindex&#039; =&gt; (int) 0,
		&#039;publish_date&#039; =&gt; object(Cake\I18n\FrozenDate) {},
		&#039;most_visit_section_id&#039; =&gt; null,
		&#039;article_big_img&#039; =&gt; null,
		&#039;liveid&#039; =&gt; (int) 21342,
		&#039;created&#039; =&gt; object(Cake\I18n\FrozenTime) {},
		&#039;modified&#039; =&gt; object(Cake\I18n\FrozenTime) {},
		&#039;edate&#039; =&gt; &#039;&#039;,
		&#039;tags&#039; =&gt; [
			[maximum depth reached]
		],
		&#039;category&#039; =&gt; object(App\Model\Entity\Category) {},
		&#039;[new]&#039; =&gt; false,
		&#039;[accessible]&#039; =&gt; [
			[maximum depth reached]
		],
		&#039;[dirty]&#039; =&gt; [[maximum depth reached]],
		&#039;[original]&#039; =&gt; [[maximum depth reached]],
		&#039;[virtual]&#039; =&gt; [[maximum depth reached]],
		&#039;[hasErrors]&#039; =&gt; false,
		&#039;[errors]&#039; =&gt; [[maximum depth reached]],
		&#039;[invalid]&#039; =&gt; [[maximum depth reached]],
		&#039;[repository]&#039; =&gt; &#039;Articles&#039;
	
	},
	&#039;articleid&#039; =&gt; (int) 21197,
	&#039;metaTitle&#039; =&gt; &#039;LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
	&#039;metaKeywords&#039; =&gt; &#039;medicines,generic drugs,Health&#039;,
	&#039;metaDesc&#039; =&gt; &#039;
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...&#039;,
	&#039;disp&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;-The Times of India&lt;/div&gt;&lt;p align=&quot;justify&quot;&gt;&lt;br /&gt;&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. &lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.&lt;/p&gt;&#039;,
	&#039;lang&#039; =&gt; &#039;English&#039;,
	&#039;SITE_URL&#039; =&gt; &#039;https://im4change.in/&#039;,
	&#039;site_title&#039; =&gt; &#039;im4change&#039;,
	&#039;adminprix&#039; =&gt; &#039;admin&#039;
]
$article_current = object(App\Model\Entity\Article) {

	&#039;id&#039; =&gt; (int) 21197,
	&#039;title&#039; =&gt; &#039;US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
	&#039;subheading&#039; =&gt; &#039;&#039;,
	&#039;description&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;
-The Times of India
&lt;/div&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;br /&gt;
&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. 
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.
&lt;/p&gt;&#039;,
	&#039;credit_writer&#039; =&gt; &#039;The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms&#039;,
	&#039;article_img&#039; =&gt; &#039;&#039;,
	&#039;article_img_thumb&#039; =&gt; &#039;&#039;,
	&#039;status&#039; =&gt; (int) 1,
	&#039;show_on_home&#039; =&gt; (int) 1,
	&#039;lang&#039; =&gt; &#039;EN&#039;,
	&#039;category_id&#039; =&gt; (int) 16,
	&#039;tag_keyword&#039; =&gt; &#039;&#039;,
	&#039;seo_url&#039; =&gt; &#039;us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342&#039;,
	&#039;meta_title&#039; =&gt; null,
	&#039;meta_keywords&#039; =&gt; null,
	&#039;meta_description&#039; =&gt; null,
	&#039;noindex&#039; =&gt; (int) 0,
	&#039;publish_date&#039; =&gt; object(Cake\I18n\FrozenDate) {},
	&#039;most_visit_section_id&#039; =&gt; null,
	&#039;article_big_img&#039; =&gt; null,
	&#039;liveid&#039; =&gt; (int) 21342,
	&#039;created&#039; =&gt; object(Cake\I18n\FrozenTime) {},
	&#039;modified&#039; =&gt; object(Cake\I18n\FrozenTime) {},
	&#039;edate&#039; =&gt; &#039;&#039;,
	&#039;tags&#039; =&gt; [
		(int) 0 =&gt; object(Cake\ORM\Entity) {},
		(int) 1 =&gt; object(Cake\ORM\Entity) {},
		(int) 2 =&gt; object(Cake\ORM\Entity) {}
	],
	&#039;category&#039; =&gt; object(App\Model\Entity\Category) {},
	&#039;[new]&#039; =&gt; false,
	&#039;[accessible]&#039; =&gt; [
		&#039;*&#039; =&gt; true,
		&#039;id&#039; =&gt; false
	],
	&#039;[dirty]&#039; =&gt; [],
	&#039;[original]&#039; =&gt; [],
	&#039;[virtual]&#039; =&gt; [],
	&#039;[hasErrors]&#039; =&gt; false,
	&#039;[errors]&#039; =&gt; [],
	&#039;[invalid]&#039; =&gt; [],
	&#039;[repository]&#039; =&gt; &#039;Articles&#039;

}
$articleid = (int) 21197
$metaTitle = &#039;LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;
$metaKeywords = &#039;medicines,generic drugs,Health&#039;
$metaDesc = &#039;
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...&#039;
$disp = &#039;&lt;div align=&quot;justify&quot;&gt;-The Times of India&lt;/div&gt;&lt;p align=&quot;justify&quot;&gt;&lt;br /&gt;&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. &lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.&lt;/p&gt;&#039;
$lang = &#039;English&#039;
$SITE_URL = &#039;https://im4change.in/&#039;
$site_title = &#039;im4change&#039;
$adminprix = &#039;admin&#039;</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342.html"/>
    <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
    <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css"
          media="all"/>
    <title>LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli | Im4change.org</title>
    <meta name="description" content="
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs..."/>
    <script src="https://im4change.in/js/jquery-1.10.2.js"></script>
    <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script>
    <script language="javascript" type="text/javascript">

        $(document).ready(function () {
            var img = $("img")[0]; // Get my img elem
            var pic_real_width, pic_real_height;
            $("<img/>") // Make in memory copy of image to avoid css issues
                .attr("src", $(img).attr("src"))
                .load(function () {
                    pic_real_width = this.width;   // Note: $(this).width() will not
                    pic_real_height = this.height; // work for in memory images.
                });
        });
    </script>
    <style type="text/css">
        @media screen {
            div.divFooter {
                display: block;
            }
        }

        @media print {
            .printbutton {
                display: none !important;
            }
        }
    </style>
</head>
<body>
<table cellpadding="0" cellspacing="0" border="0" width="98%" align="center">
    <tr>
        <td class="top_bg">
            <div class="divFooter">
                <img src="https://im4change.in/images/logo1.jpg" height="59" border="0"
                     alt="Resource centre on India's rural distress" style="padding-top:14px;"/>
            </div>

        </td>
    </tr>
    <tr>
        <td id="topspace">&nbsp;</td>
    </tr>

    <tr id="topspace">
        <td>&nbsp;</td>
    </tr>
    <tr>
        <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton">
            <form><input type="button" value=" Print this page "
                         onclick="window.print();return false;"/></form>
        </td>
    </tr>

    <tr>
        <td width="100%">
            <h1 class="news_headlines" style="font-style:normal">
                <strong>US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli</strong></h1>
        </td>
    </tr>
    <tr>
        <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3">
                <div align="justify">-The Times of India</div><p align="justify"><br /><em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.</p><p align="justify">Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.</p><p align="justify">&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. </p><p align="justify">It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.</p><p align="justify">&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;</p><p align="justify">At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.</p><p align="justify"><em>More Indian pharma cos come under FDA scrutiny</em></p><p align="justify">Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.</p><p align="justify">Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.</p><p align="justify">While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.</p>               </font>
        </td>
    </tr>
    <tr>
        <td>&nbsp;</td>
    </tr>

    <tr>
        <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;">
            <form><input type="button" value=" Print this page "
                         onclick="window.print();return false;"/></form>
        </td>
    </tr>
</table></body>
</html>'

}
$reasonPhrase = 'OK'
header - [internal], line ??
Cake\Http\ResponseEmitter::emitStatusLine() - CORE/src/Http/ResponseEmitter.php, line 148
Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 54
Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141
[main] - ROOT/webroot/index.php, line 39

Warning (2): Cannot modify header information - headers already sent by (output started at /home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php:853) [CORE/src/Http/ResponseEmitter.php, line 181]
Code Context
                    $value

                ), $first);

                $first = false;
$response = object(Cake\Http\Response) {

	'status' => (int) 200,
	'contentType' => 'text/html',
	'headers' => [
		'Content-Type' => [
			[maximum depth reached]
		]
	],
	'file' => null,
	'fileRange' => [],
	'cookies' => object(Cake\Http\Cookie\CookieCollection) {},
	'cacheDirectives' => [],
	'body' => '<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
        "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
    <link rel="canonical" href="https://im4change.in/<pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-trace').style.display = (document.getElementById('cakeErr67f71f0467a3f-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: urlPrefix [<b>APP/Template/Layout/printlayout.ctp</b>, line <b>8</b>]<div id="cakeErr67f71f0467a3f-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-code').style.display = (document.getElementById('cakeErr67f71f0467a3f-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr67f71f0467a3f-context').style.display = (document.getElementById('cakeErr67f71f0467a3f-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr67f71f0467a3f-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000"><span style="color: #0000BB"></span><span style="color: #007700">&lt;</span><span style="color: #0000BB">head</span><span style="color: #007700">&gt;
</span></span></code>
<span class="code-highlight"><code><span style="color: #000000">&nbsp;&nbsp;&nbsp;&nbsp;&lt;link&nbsp;rel="canonical"&nbsp;href="<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">);&nbsp;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">category</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">slug</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>/<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">seo_url</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>.html"/&gt;
</span></code></span>
<code><span style="color: #000000"><span style="color: #0000BB">&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="color: #007700">&lt;</span><span style="color: #0000BB">meta&nbsp;http</span><span style="color: #007700">-</span><span style="color: #0000BB">equiv</span><span style="color: #007700">=</span><span style="color: #DD0000">"Content-Type"&nbsp;</span><span style="color: #0000BB">content</span><span style="color: #007700">=</span><span style="color: #DD0000">"text/html;&nbsp;charset=utf-8"</span><span style="color: #007700">/&gt;
</span></span></code></pre><pre id="cakeErr67f71f0467a3f-context" class="cake-context" style="display: none;">$viewFile = &#039;/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp&#039;
$dataForView = [
	&#039;article_current&#039; =&gt; object(App\Model\Entity\Article) {

		&#039;id&#039; =&gt; (int) 21197,
		&#039;title&#039; =&gt; &#039;US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
		&#039;subheading&#039; =&gt; &#039;&#039;,
		&#039;description&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;
-The Times of India
&lt;/div&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;br /&gt;
&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. 
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.
&lt;/p&gt;&#039;,
		&#039;credit_writer&#039; =&gt; &#039;The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms&#039;,
		&#039;article_img&#039; =&gt; &#039;&#039;,
		&#039;article_img_thumb&#039; =&gt; &#039;&#039;,
		&#039;status&#039; =&gt; (int) 1,
		&#039;show_on_home&#039; =&gt; (int) 1,
		&#039;lang&#039; =&gt; &#039;EN&#039;,
		&#039;category_id&#039; =&gt; (int) 16,
		&#039;tag_keyword&#039; =&gt; &#039;&#039;,
		&#039;seo_url&#039; =&gt; &#039;us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342&#039;,
		&#039;meta_title&#039; =&gt; null,
		&#039;meta_keywords&#039; =&gt; null,
		&#039;meta_description&#039; =&gt; null,
		&#039;noindex&#039; =&gt; (int) 0,
		&#039;publish_date&#039; =&gt; object(Cake\I18n\FrozenDate) {},
		&#039;most_visit_section_id&#039; =&gt; null,
		&#039;article_big_img&#039; =&gt; null,
		&#039;liveid&#039; =&gt; (int) 21342,
		&#039;created&#039; =&gt; object(Cake\I18n\FrozenTime) {},
		&#039;modified&#039; =&gt; object(Cake\I18n\FrozenTime) {},
		&#039;edate&#039; =&gt; &#039;&#039;,
		&#039;tags&#039; =&gt; [
			[maximum depth reached]
		],
		&#039;category&#039; =&gt; object(App\Model\Entity\Category) {},
		&#039;[new]&#039; =&gt; false,
		&#039;[accessible]&#039; =&gt; [
			[maximum depth reached]
		],
		&#039;[dirty]&#039; =&gt; [[maximum depth reached]],
		&#039;[original]&#039; =&gt; [[maximum depth reached]],
		&#039;[virtual]&#039; =&gt; [[maximum depth reached]],
		&#039;[hasErrors]&#039; =&gt; false,
		&#039;[errors]&#039; =&gt; [[maximum depth reached]],
		&#039;[invalid]&#039; =&gt; [[maximum depth reached]],
		&#039;[repository]&#039; =&gt; &#039;Articles&#039;
	
	},
	&#039;articleid&#039; =&gt; (int) 21197,
	&#039;metaTitle&#039; =&gt; &#039;LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
	&#039;metaKeywords&#039; =&gt; &#039;medicines,generic drugs,Health&#039;,
	&#039;metaDesc&#039; =&gt; &#039;
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...&#039;,
	&#039;disp&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;-The Times of India&lt;/div&gt;&lt;p align=&quot;justify&quot;&gt;&lt;br /&gt;&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. &lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.&lt;/p&gt;&#039;,
	&#039;lang&#039; =&gt; &#039;English&#039;,
	&#039;SITE_URL&#039; =&gt; &#039;https://im4change.in/&#039;,
	&#039;site_title&#039; =&gt; &#039;im4change&#039;,
	&#039;adminprix&#039; =&gt; &#039;admin&#039;
]
$article_current = object(App\Model\Entity\Article) {

	&#039;id&#039; =&gt; (int) 21197,
	&#039;title&#039; =&gt; &#039;US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;,
	&#039;subheading&#039; =&gt; &#039;&#039;,
	&#039;description&#039; =&gt; &#039;&lt;div align=&quot;justify&quot;&gt;
-The Times of India
&lt;/div&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;br /&gt;
&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. 
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
&lt;/p&gt;
&lt;p align=&quot;justify&quot;&gt;
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.
&lt;/p&gt;&#039;,
	&#039;credit_writer&#039; =&gt; &#039;The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms&#039;,
	&#039;article_img&#039; =&gt; &#039;&#039;,
	&#039;article_img_thumb&#039; =&gt; &#039;&#039;,
	&#039;status&#039; =&gt; (int) 1,
	&#039;show_on_home&#039; =&gt; (int) 1,
	&#039;lang&#039; =&gt; &#039;EN&#039;,
	&#039;category_id&#039; =&gt; (int) 16,
	&#039;tag_keyword&#039; =&gt; &#039;&#039;,
	&#039;seo_url&#039; =&gt; &#039;us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342&#039;,
	&#039;meta_title&#039; =&gt; null,
	&#039;meta_keywords&#039; =&gt; null,
	&#039;meta_description&#039; =&gt; null,
	&#039;noindex&#039; =&gt; (int) 0,
	&#039;publish_date&#039; =&gt; object(Cake\I18n\FrozenDate) {},
	&#039;most_visit_section_id&#039; =&gt; null,
	&#039;article_big_img&#039; =&gt; null,
	&#039;liveid&#039; =&gt; (int) 21342,
	&#039;created&#039; =&gt; object(Cake\I18n\FrozenTime) {},
	&#039;modified&#039; =&gt; object(Cake\I18n\FrozenTime) {},
	&#039;edate&#039; =&gt; &#039;&#039;,
	&#039;tags&#039; =&gt; [
		(int) 0 =&gt; object(Cake\ORM\Entity) {},
		(int) 1 =&gt; object(Cake\ORM\Entity) {},
		(int) 2 =&gt; object(Cake\ORM\Entity) {}
	],
	&#039;category&#039; =&gt; object(App\Model\Entity\Category) {},
	&#039;[new]&#039; =&gt; false,
	&#039;[accessible]&#039; =&gt; [
		&#039;*&#039; =&gt; true,
		&#039;id&#039; =&gt; false
	],
	&#039;[dirty]&#039; =&gt; [],
	&#039;[original]&#039; =&gt; [],
	&#039;[virtual]&#039; =&gt; [],
	&#039;[hasErrors]&#039; =&gt; false,
	&#039;[errors]&#039; =&gt; [],
	&#039;[invalid]&#039; =&gt; [],
	&#039;[repository]&#039; =&gt; &#039;Articles&#039;

}
$articleid = (int) 21197
$metaTitle = &#039;LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&amp;#039;s TN unit -Rajesh Chandramouli&#039;
$metaKeywords = &#039;medicines,generic drugs,Health&#039;
$metaDesc = &#039;
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...&#039;
$disp = &#039;&lt;div align=&quot;justify&quot;&gt;-The Times of India&lt;/div&gt;&lt;p align=&quot;justify&quot;&gt;&lt;br /&gt;&lt;em&gt;CHENNAI: &lt;/em&gt;The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&amp;quot; the FDA letter said. &lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&amp;quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&amp;quot; a Hospira spokesman said. &amp;quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&amp;quot;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA&#039;s scrutiny in the recent past.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;&lt;em&gt;More Indian pharma cos come under FDA scrutiny&lt;/em&gt;&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;Indian pharmaceutical companies have also recently come under the FDA&#039;s scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.&lt;/p&gt;&lt;p align=&quot;justify&quot;&gt;While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &amp;quot;import alert&amp;quot; on a plant operated by Wockhardt in Maharashtra on May 22.&lt;/p&gt;&#039;
$lang = &#039;English&#039;
$SITE_URL = &#039;https://im4change.in/&#039;
$site_title = &#039;im4change&#039;
$adminprix = &#039;admin&#039;</pre><pre class="stack-trace">include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51</pre></div></pre>latest-news-updates/us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342.html"/>
    <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>
    <link href="https://im4change.in/css/control.css" rel="stylesheet" type="text/css"
          media="all"/>
    <title>LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli | Im4change.org</title>
    <meta name="description" content="
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs..."/>
    <script src="https://im4change.in/js/jquery-1.10.2.js"></script>
    <script type="text/javascript" src="https://im4change.in/js/jquery-migrate.min.js"></script>
    <script language="javascript" type="text/javascript">

        $(document).ready(function () {
            var img = $("img")[0]; // Get my img elem
            var pic_real_width, pic_real_height;
            $("<img/>") // Make in memory copy of image to avoid css issues
                .attr("src", $(img).attr("src"))
                .load(function () {
                    pic_real_width = this.width;   // Note: $(this).width() will not
                    pic_real_height = this.height; // work for in memory images.
                });
        });
    </script>
    <style type="text/css">
        @media screen {
            div.divFooter {
                display: block;
            }
        }

        @media print {
            .printbutton {
                display: none !important;
            }
        }
    </style>
</head>
<body>
<table cellpadding="0" cellspacing="0" border="0" width="98%" align="center">
    <tr>
        <td class="top_bg">
            <div class="divFooter">
                <img src="https://im4change.in/images/logo1.jpg" height="59" border="0"
                     alt="Resource centre on India's rural distress" style="padding-top:14px;"/>
            </div>

        </td>
    </tr>
    <tr>
        <td id="topspace">&nbsp;</td>
    </tr>

    <tr id="topspace">
        <td>&nbsp;</td>
    </tr>
    <tr>
        <td height="50" style="border-bottom:1px solid #000; padding-top:10px;" class="printbutton">
            <form><input type="button" value=" Print this page "
                         onclick="window.print();return false;"/></form>
        </td>
    </tr>

    <tr>
        <td width="100%">
            <h1 class="news_headlines" style="font-style:normal">
                <strong>US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli</strong></h1>
        </td>
    </tr>
    <tr>
        <td width="100%" style="font-family:Arial, 'Segoe Script', 'Segoe UI', sans-serif, serif"><font size="3">
                <div align="justify">-The Times of India</div><p align="justify"><br /><em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.</p><p align="justify">Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.</p><p align="justify">&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. </p><p align="justify">It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.</p><p align="justify">&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;</p><p align="justify">At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.</p><p align="justify"><em>More Indian pharma cos come under FDA scrutiny</em></p><p align="justify">Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.</p><p align="justify">Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.</p><p align="justify">While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.</p>               </font>
        </td>
    </tr>
    <tr>
        <td>&nbsp;</td>
    </tr>

    <tr>
        <td height="50" style="border-top:1px solid #000; border-bottom:1px solid #000;padding-top:10px;">
            <form><input type="button" value=" Print this page "
                         onclick="window.print();return false;"/></form>
        </td>
    </tr>
</table></body>
</html>'

}
$cookies = []
$values = [
	(int) 0 => 'text/html; charset=UTF-8'
]
$name = 'Content-Type'
$first = true
$value = 'text/html; charset=UTF-8'
header - [internal], line ??
Cake\Http\ResponseEmitter::emitHeaders() - CORE/src/Http/ResponseEmitter.php, line 181
Cake\Http\ResponseEmitter::emit() - CORE/src/Http/ResponseEmitter.php, line 55
Cake\Http\Server::emit() - CORE/src/Http/Server.php, line 141
[main] - ROOT/webroot/index.php, line 39

<head>

    <link rel="canonical" href="<?php echo Configure::read('SITE_URL'); ?><?php echo $urlPrefix;?><?php echo $article_current->category->slug; ?>/<?php echo $article_current->seo_url; ?>.html"/>

    <meta http-equiv="Content-Type" content="text/html; charset=utf-8"/>

$viewFile = '/home/brlfuser/public_html/src/Template/Layout/printlayout.ctp'
$dataForView = [
	'article_current' => object(App\Model\Entity\Article) {

		'id' => (int) 21197,
		'title' => 'US drug regulator detects lapses in Hospira's TN unit -Rajesh Chandramouli',
		'subheading' => '',
		'description' => '<div align="justify">
-The Times of India
</div>
<p align="justify">
<br />
<em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
</p>
<p align="justify">
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
</p>
<p align="justify">
&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. 
</p>
<p align="justify">
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
</p>
<p align="justify">
&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;
</p>
<p align="justify">
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.
</p>
<p align="justify">
<em>More Indian pharma cos come under FDA scrutiny</em>
</p>
<p align="justify">
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
</p>
<p align="justify">
Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
</p>
<p align="justify">
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.
</p>',
		'credit_writer' => 'The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms',
		'article_img' => '',
		'article_img_thumb' => '',
		'status' => (int) 1,
		'show_on_home' => (int) 1,
		'lang' => 'EN',
		'category_id' => (int) 16,
		'tag_keyword' => '',
		'seo_url' => 'us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342',
		'meta_title' => null,
		'meta_keywords' => null,
		'meta_description' => null,
		'noindex' => (int) 0,
		'publish_date' => object(Cake\I18n\FrozenDate) {},
		'most_visit_section_id' => null,
		'article_big_img' => null,
		'liveid' => (int) 21342,
		'created' => object(Cake\I18n\FrozenTime) {},
		'modified' => object(Cake\I18n\FrozenTime) {},
		'edate' => '',
		'tags' => [
			[maximum depth reached]
		],
		'category' => object(App\Model\Entity\Category) {},
		'[new]' => false,
		'[accessible]' => [
			[maximum depth reached]
		],
		'[dirty]' => [[maximum depth reached]],
		'[original]' => [[maximum depth reached]],
		'[virtual]' => [[maximum depth reached]],
		'[hasErrors]' => false,
		'[errors]' => [[maximum depth reached]],
		'[invalid]' => [[maximum depth reached]],
		'[repository]' => 'Articles'
	
	},
	'articleid' => (int) 21197,
	'metaTitle' => 'LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli',
	'metaKeywords' => 'medicines,generic drugs,Health',
	'metaDesc' => '
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...',
	'disp' => '<div align="justify">-The Times of India</div><p align="justify"><br /><em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.</p><p align="justify">Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.</p><p align="justify">&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. </p><p align="justify">It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.</p><p align="justify">&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;</p><p align="justify">At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.</p><p align="justify"><em>More Indian pharma cos come under FDA scrutiny</em></p><p align="justify">Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.</p><p align="justify">Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.</p><p align="justify">While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.</p>',
	'lang' => 'English',
	'SITE_URL' => 'https://im4change.in/',
	'site_title' => 'im4change',
	'adminprix' => 'admin'
]
$article_current = object(App\Model\Entity\Article) {

	'id' => (int) 21197,
	'title' => 'US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli',
	'subheading' => '',
	'description' => '<div align="justify">
-The Times of India
</div>
<p align="justify">
<br />
<em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.
</p>
<p align="justify">
Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.
</p>
<p align="justify">
&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. 
</p>
<p align="justify">
It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.
</p>
<p align="justify">
&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;
</p>
<p align="justify">
At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.
</p>
<p align="justify">
<em>More Indian pharma cos come under FDA scrutiny</em>
</p>
<p align="justify">
Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.
</p>
<p align="justify">
Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.
</p>
<p align="justify">
While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.
</p>',
	'credit_writer' => 'The Times of India, 31 May, 2013, http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms',
	'article_img' => '',
	'article_img_thumb' => '',
	'status' => (int) 1,
	'show_on_home' => (int) 1,
	'lang' => 'EN',
	'category_id' => (int) 16,
	'tag_keyword' => '',
	'seo_url' => 'us-drug-regulator-detects-lapses-in-hospira039s-tn-unit-rajesh-chandramouli-21342',
	'meta_title' => null,
	'meta_keywords' => null,
	'meta_description' => null,
	'noindex' => (int) 0,
	'publish_date' => object(Cake\I18n\FrozenDate) {},
	'most_visit_section_id' => null,
	'article_big_img' => null,
	'liveid' => (int) 21342,
	'created' => object(Cake\I18n\FrozenTime) {},
	'modified' => object(Cake\I18n\FrozenTime) {},
	'edate' => '',
	'tags' => [
		(int) 0 => object(Cake\ORM\Entity) {},
		(int) 1 => object(Cake\ORM\Entity) {},
		(int) 2 => object(Cake\ORM\Entity) {}
	],
	'category' => object(App\Model\Entity\Category) {},
	'[new]' => false,
	'[accessible]' => [
		'*' => true,
		'id' => false
	],
	'[dirty]' => [],
	'[original]' => [],
	'[virtual]' => [],
	'[hasErrors]' => false,
	'[errors]' => [],
	'[invalid]' => [],
	'[repository]' => 'Articles'

}
$articleid = (int) 21197
$metaTitle = 'LATEST NEWS UPDATES | US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli'
$metaKeywords = 'medicines,generic drugs,Health'
$metaDesc = '
-The Times of India



CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs...'
$disp = '<div align="justify">-The Times of India</div><p align="justify"><br /><em>CHENNAI: </em>The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US.</p><p align="justify">Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs.</p><p align="justify">&quot;Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...,&quot; the FDA letter said. </p><p align="justify">It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days.</p><p align="justify">&quot;We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants,&quot; a Hospira spokesman said. &quot;Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter.&quot;</p><p align="justify">At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past.</p><p align="justify"><em>More Indian pharma cos come under FDA scrutiny</em></p><p align="justify">Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&amp;D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010.</p><p align="justify">Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices.</p><p align="justify">While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an &quot;import alert&quot; on a plant operated by Wockhardt in Maharashtra on May 22.</p>'
$lang = 'English'
$SITE_URL = 'https://im4change.in/'
$site_title = 'im4change'
$adminprix = 'admin'

include - APP/Template/Layout/printlayout.ctp, line 8
Cake\View\View::_evaluate() - CORE/src/View/View.php, line 1413
Cake\View\View::_render() - CORE/src/View/View.php, line 1374
Cake\View\View::renderLayout() - CORE/src/View/View.php, line 927
Cake\View\View::render() - CORE/src/View/View.php, line 885
Cake\Controller\Controller::render() - CORE/src/Controller/Controller.php, line 791
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 126
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51

US drug regulator detects lapses in Hospira's TN unit -Rajesh Chandramouli

-The Times of India CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US. Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an October inspection of the plant, where FDA said it found significant violations of quality regulations for finished drugs. "Surfaces are not always sanitized.... aseptic manufacturing intervention is not performed ...gloves used during manufacture of sterile products are used without adequate assurance of their sterility ...," the FDA letter said. It asked the company to notify steps taken to correct and prevent recurrence of deviations within 30 days. "We are in the process of reviewing the letter, but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants," a Hospira spokesman said. "Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter." At least two other Indian drug makers, Ranbaxy and Wockhardt, have similarly come under the FDA's scrutiny in the recent past. More Indian pharma cos come under FDA scrutiny Hospira entered into an agreement in March 2010 to buy the factory from Orchid Chemicals which makes generic injectable finished dosage. The plant makes beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin , penicillin and carbapenem facilities) and also houses a pharmaceutical research and development (R&D) facility. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010. Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy and Wockhardt faced issues related to manufacturing practices. While Ranbaxy agreed to pay $500 million in civil and criminal fines under a settlement agreement with the US Department of Justice, after it pleaded guilty to three criminal counts related to the manufacture of drugs at two Indian locations. The FDA imposed an "import alert" on a plant operated by Wockhardt in Maharashtra on May 22.