Piramal Pharma's Lexington facility receives FDA observations

Piramal Pharma Limited announced today that its Lexington, Kentucky facility underwent a general Good Manufacturing Practices (GMP) inspection by the US FDA from December 3rd to December 10th, 2025. The inspection concluded with the issuance of a Form-483, detailing four observations.

These observations relate to enhancements in procedures and are classified as a Voluntary Action Indicated (VAI). Piramal Pharma is currently preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.

The company affirmed its commitment to maintaining the highest standards of compliance and will collaborate closely with the agency to address all observations comprehensively.