The United States Food and Drug Administration (USFDA) has concluded the General GMP inspection at Piramal Pharma’s Turbhe facility. The inspection conducted from February 11, 2025 to February 17, 2025.
On conclusion of the inspection, a Form-483 was issued with 6 observations. Observations are largely around improvement of procedures and practices and not related to data integrity. The Company is preparing a detailed response to said observations, which will be submitted to agency within stipulated timelines. The Company remains committed to maintain a highest standards of compliance and is confident of effective closure of 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.
