Piramal Pharma's Lexington Facility Receives Form-483 from US FDA with Four Observations

Piramal Pharma Limited's Lexington (Kentucky, USA) facility underwent a general Good Manufacturing Practices (GMP) inspection by the US FDA from 3rd to 10th December, 2025. The inspection resulted in the issuance of a Form-483 with four observations. These observations are classified as a VAI (voluntary action indicated), indicating the need for enhancement in procedures. Piramal Pharma is preparing a detailed response to these observations, which will be submitted to the US FDA within the stipulated timelines. The company remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the observations.