United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) inspection at Piramal Pharma’s Riverview (USA) facility from January 29, 2024 to February 6, 2024.
On conclusion of the inspection, a Form-483 was issued with 3 observations. The observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity. The company is preparing a detailed response to said observations, which will be submitted to the USFDA within 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.
