Torrent Pharmaceuticals Ltd said Thursday that its manufacturing facility in Levittown, Pennsylvania, USA, has successfully completed the inspection of the USFDA.
The plant was inspected by USFDA (US Food and Drug Administration) between December 6 and December 15, 2021. At the end of the inspection, a 'Form 483' was not issued, the company said in a regulatory filing.
According to the USFDA, Form 483 is issued to the management of a company at the conclusion of an inspection when an investigator has observed any condition that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related laws. .
"It is a positive development for the company and is a reflection of our commitment to consistency in quality and compliance with regulatory standards." Torrent Pharmaceuticals saying.
According to information available on the company's website, the Levittown manufacturing facility is part of Torrent Pharma's 2018 acquisition of Bio-Pharm, Inc (BPI). It has manufacturing capabilities of controlled substances that can be manufactured In the US Government only. guidelines.
(Only the headline and image for this report may have been edited by Business Standard staff; other content is automatically generated from a syndicated feed.)
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