FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - October 12, 2023

Dr. Reddy's Laboratories, Ltd, Biologics in Hyderabad, India, was cited for significant deficiencies in its drug substance and drug product manufacturing processes. The inspection revealed critical issues including inadequate viral control strategies, widespread mold contamination, insufficient investigations into product defects, and a lack of process control and validation for sterilization and cleaning. These findings indicate a severe lack of control over manufacturing operations, posing risks to product quality and patient safety.