FDA gives out 483 form to Torrent Pharma citing "inadaquate cleaning procedure"

Published: 26-Oct-2022
Regulatory Cleaning Pharmaceutical

The pharma giant from India has been give the form citing three main issues

Torrent Pharma has encountered trouble with the FDA again in 2022, after a dalliance with them back in 2019 over nitrosamine impurities of sartan products.

This time around, the communication from the FDA takes the form of a 483 form, the notice of non-compliance that preceeds a warning letter.

The 15-page form details three main observations at the over 1 million sqm API and finished product manufacturing facility in India.

These three observations covered insufficient cleaning of equipment to remove residues of previous manufacturing, insufficient batch failure and discrepancy investigation, and insufficient follow-ups to drug complaints.

The inspection took place in late September, with the form issue on the 28th. Soon after Torrent had replied to the FDA saying: "None of these observations were related to data integrity. We will respond to the USFDA within stipulated timeline and work closely with USFDA to address the observations at the earliest."

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  • US Food and Drug Administration (FDA)
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