United States Food and Drug Administration (USFDA) has concluded general Good Manufacturing Practices (GMP) inspection at Piramal Pharma’s Lexington (Kentucky, USA) facility. The inspection was conducted from December 03, 2025 to December 10, 2025.
At the conclusion of the inspection, the USFDA issued a Form-483, with four observations. These observations are related to enhancement in procedures and will be classified as a VAI (voluntary action indicated). The Company is preparing a detailed response to the observations, which will be submitted to the US FDA 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.
