FDA 483 - Biocon Biologics Limited

Biocon Biologics Limited, a drug substance manufacturer in Electronics City Bengaluru, India, was cited for significant deficiencies across its facilities, equipment, quality control, and laboratory systems. Observations included inadequate sanitation and equipment maintenance, failure to thoroughly investigate out-of-specification results and system integrity, and lack of established laboratory control mechanisms. These issues indicate a systemic breakdown in maintaining a state of control and ensuring product quality.