FDA 483 - Cohance Lifesciences Limited - March 07, 2025

Cohance Lifesciences Limited, an Active Pharmaceutical Ingredient Manufacturer in Hyderabad, India, was inspected by the FDA from March 3-7, 2025. The inspection revealed significant deficiencies across quality control, including inadequate review of laboratory incidents and OOS investigations, unvalidated analytical methods, deficient equipment qualification, and failures in quality unit responsibilities. These issues indicate a lack of robust quality systems for ensuring product quality and data integrity.