United States Food and Drug Administration (USFDA) has conducted a Good Manufacturing Practices (GMP) inspection of Piramal Pharma’s Sellersville (USA) facility from May 04, 2026 to May 08, 2026.
At the conclusion of the inspection, USFDA issued a Form-483, with three observations. At the closing meeting observations were recommended to be classified under VAI (Voluntary Action Indicated) by inspectors. None of the observation relate to data integrity. The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.
Piramal Pharma provides end-to-end pharma services to customers and a portfolio of differentiated pharma products across a domestic and global distribution network.
