United States Food and Drug Administration (USFDA) has concluded a general Good Manufacturing Practices (GMP) inspection at Piramal Pharma’s Digwal, Telangana, India facility. The inspection was conducted from February 09, 2026 to February 13, 2026.
At the conclusion of the inspection, the US FDA issued a Form-483, with 4 observations. These observations are related to enhancement in procedures and not related to data integrity and are indicated to be classified as a VAI (voluntary action indicated). 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.
