FDA 483 - NATCO Pharma Limited Chemical Division Chennai - November 21, 2025

NATCO Pharma Limited Chemical Division, an API manufacturer in Chennai, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate OOS investigations and CAPA implementation, unvalidated manufacturing processes, and poor laboratory and equipment controls. The firm also demonstrated issues with quality unit procedures, facility maintenance, and computer system controls, indicating a broad lack of adherence to cGMP requirements.