22 Apr 2016
Glenmark Pharmaceuticals has received three observations from the US health regulator for its Pithampur, Indore (India) plant. The Pithampur plant was inspected by USFDA in February 2016 and we received three observations from them which were responded to in March 2016. As per company’s claim, the issues already been addressed and same has been rectified.
Companies that receive USFDA observations in Form 483 must respond in writing with a corrective action plan and implement the same quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.
The USFDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice standards laid down by it.