FDA 483 - Glenmark Pharmaceuticals Ltd - February 14, 2025

An FDA inspection of Glenmark Pharmaceuticals Ltd in Pithampur, India, revealed critical deficiencies in contamination control, facility segregation, and quality control. The firm failed to prevent cross-contamination due to inadequate cleaning and shared manufacturing areas for potent drugs. Additionally, there were significant issues with OOS investigations, analytical method validation, and timely completion of stability studies, indicating a systemic breakdown in quality assurance.