Piramal Pharma Faces Four USFDA Observations After Routine Lexington Facility Inspection

12 Dec 2025 , 11:10 AM

Piramal Pharma told the stock exchanges on December 11 that the US FDA raised four observations after completing a routine GMP check at the company’s Lexington site in Kentucky.

The regulator had visited the plant between December 3 and December 10, 2025. According to the company, this was a standard inspection carried out to assess how the facility is following prescribed manufacturing practices.

Piramal Pharma said the remarks largely point to areas where internal procedures can be strengthened. It also clarified that none of the points suggest any serious concern around the plant’s operations.

The firm expects the observations to be placed under the VAI category, which indicates that the issues highlighted do not call for compulsory regulatory action and can be resolved voluntarily.

A detailed response is currently being drafted, and the company plans to send it to the US FDA within the given timeline as part of its regular compliance process. Piramal added that it remains committed to strong quality systems across its operations. The firm said it will continue working with the US regulator to close out the observations in a complete and time-bound manner.

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