USFDA inspection of company’s US plant completed successfully: Torrent Pharmaceuticals

Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. (Representative image)
The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. (Representative image)

Torrent Pharmaceuticals Ltd on Thursday said its manufacturing facility at Levittown, Pennsylvania in the US has successfully completed inspection by the USFDA.

The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. At the end of the inspection, no ‘Form 483’ was issued, the company said in a regulatory filing.

As per the USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

“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 said.

According to information available on the company’s website, the Levittown manufacturing facility is a part of Torrent Pharma’s acquisition of Bio-Pharm, Inc (BPI) in 2018. It has manufacturing capabilities for controlled substances which can be manufactured in the US only as per government guidelines.

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