Piramal Pharma Gets 3 USFDA Observations at US Facility
New Delhi: Piramal Pharma Limited has informed stock exchanges that the United States Food and Drug Administration (US FDA) conducted a Good Manufacturing Practices (GMP) inspection at the company's Sellersville facility in the United States between May 4 and May 8, 2026.
Following the inspection, the US FDA issued a Form 483 containing three observations. The company stated that during the closing meeting, inspectors recommended that the observations be classified under Voluntary Action Indicated (VAI). Piramal Pharma further clarified that none of the observations are related to data integrity issues.
The company said it is preparing a detailed response to the observations and will submit it to the US FDA within the prescribed timelines. Piramal Pharma also reiterated its commitment to maintaining high standards of regulatory compliance and said it will work closely with the US regulator to address all observations comprehensively.
