“This is to inform you that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited’s Morpeth, UK facility from 3rd September, 2026 to 11th September, 2026,” according to a stock exchange filing.
Piramal Pharma said the observations relate to enhancements in its practices, procedures and documentation. The company said it is addressing the observations and preparing a detailed response for submission to the US FDA within the stipulated timeline.
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“At the conclusion of the inspection, the US FDA issued a Form 483 with 7 observations. These observations are related to enhancement in our practices, procedures and documentation. The Company is diligently addressing these observations and is preparing a detailed response for submission to the US FDA within the stipulated timeline,” it said.
Piramal Pharma said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all seven observations.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
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After Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
On Shares of Piramal Pharma Ltd ended at ₹211.90, down by ₹0.60, or 0.28%, on the BSE.
