Piramal Pharma gets four observations from US FDA after Lexington facility inspection

Piramal Pharma Ltd on Thursday, December 11, said the US Food and Drug Administration (US FDA) has issued a Form 483 with four observations following a routine Good Manufacturing Practices (GMP) inspection

at its Lexington, Kentucky, facility.

The inspection was conducted between December 3 and December 10, 2025, the company said in a regulatory filing.

Piramal Pharma noted that the observations relate to procedural enhancements and are expected to be classified as VAI (Voluntary Action Indicated), the category that does not require any mandatory regulatory action.

The company said it is preparing a detailed response, which will be submitted to the US FDA within the stipulated timeframe.

Piramal added that it remains committed to maintaining the highest levels of quality and compliance and will work closely with the regulator to address the observations comprehensively.

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Shares of Piramal Pharma Ltd ended higher on Thursday, December 11, by 0.65% at ₹172.10 on the NSE.