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: 150
 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);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 150
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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: 151
 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);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
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 97
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')) {

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                            <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>                                                           
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    <h1 class="cat-box-title">US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli</h1>
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                            <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>                                                           
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    <h1 class="cat-box-title">US drug regulator detects lapses in Hospira&#039;s TN unit -Rajesh Chandramouli</h1>
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                            <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>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/business/india-business/US-drug-regulator-detects-lapses-in-Hospiras-TN-unit/articleshow/20359476.cms" class="re" target="_blank">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</a><div class="clear"></div>
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US drug regulator detects lapses in Hospira's TN unit -Rajesh Chandramouli

Published on May 31, 2013   Modified on May 31, 2013

-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.

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

Tagged with: medicines generic drugs Health

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