FDA 483 - Dr. Reddy's Laboratories Limited (Unit II) - November 19, 2024

An FDA inspection of Dr. Reddy's Laboratories Limited (Unit II) in Hyderabad, India, revealed significant deficiencies across multiple systems, including repeat observations for inadequate complaint investigations and computer system controls. The firm failed to maintain manufacturing processes in a validated state, exhibited poor quality control unit procedures, and lacked robust laboratory controls. These findings indicate a systemic failure to ensure the quality, purity, and compliance of Active Pharmaceutical Ingredients (APIs) destined for the US market.