Piramal Pharma Ltd
š US FDA Issues Form-483 with 3 Observations After Piramal Pharma Facility Inspection
- US FDA conducted a GMP inspection at Piramal Pharma's Sellersville (USA) facility from May 4 to May 8, 2026.
- US FDA issued a Form-483 with three observations, recommended to be classified as Voluntary Action Indicated (VAI).
- None of the observations relate to data integrity issues.
- Company is preparing a detailed response to submit to US FDA within stipulated timelines.
- Company commits to maintaining high compliance standards and working closely with FDA to address observations.