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]
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]
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]
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]
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]
Notice (8): Undefined variable: urlPrefix [APP/Template/Layout/printlayout.ctp, line 8]latest-news-updates/for-poor-manufacturing-practices-indian-pharma-company-gets-warning-letter-from-us-fda.html"/> LATEST NEWS UPDATES | For Poor Manufacturing Practices, Indian Pharma Company Gets ‘Warning Letter’ From US FDA | Im4change.org
Resource centre on India's rural distress
 
 

For Poor Manufacturing Practices, Indian Pharma Company Gets ‘Warning Letter’ From US FDA

-TheWire.in

The US drug regulator says Lupin Limited's response to tackling genotoxic impurities was not adequate.

New Delhi: The US Food and Drug Administration (FDA) has sent a warning letter to the Indian pharmaceutical company Lupin Limited after deeming its efforts to address violations of various good manufacturing practices at its facility in Tarapur, Maharashtra “inadequate”.

The FDA sends a ‘warning letter’ to a manufacturer if it has “significantly violated” the agency’s regulations. Violations may be poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The manufacturer is directed to correct the problem within a specific timeframe.

Please click here to read more.