Piramal Pharma Limited said the US Food and Drug Administration (US FDA) has issued a Form 483 with three observations following a Good Manufacturing Practices (GMP) inspection at its Sellersville facility in the US.
The inspection was conducted from May 4 to May 8, 2026. At the close-out meeting, the observations were recommended by inspectors to be classified under Voluntary Action Indicated (VAI), the company said in a regulatory filing on Sunday. Importantly, none of the observations relate to data integrity.
Piramal Pharma said it is preparing a detailed response to the observations and will submit it to the US FDA within the stipulated timelines.
“The Company remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all the observations,” the Company said in their exchange filing.
Form 483 is issued by the US FDA to communicate inspectional observations that may not fully comply with regulatory requirements. Companies are suggested to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
