Piramal Pharma Ltd Receives Form-483 from US FDA with 4 Observations

Piramal Pharma Limited's Digwal, Telangana, India facility underwent a general Good Manufacturing Practices (GMP) inspection by the US FDA from 9th to 13th February 2026. The inspection resulted in the issuance of a Form-483 with 4 observations. These observations are not related to data integrity and are classified as a VAI (voluntary action indicated). The company is preparing a detailed response to these observations, which will be submitted to the US FDA within the stipulated timelines. Piramal Pharma remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the observations.