FDA 483 - Biocon Biologics Limited

Biocon Limited, a drug product manufacturer in Bangalore, India, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed inadequate procedures and practices to prevent microbiological contamination during sterile drug product filling operations, alongside a failure to conduct thorough investigations into environmental monitoring excursions with effective corrective actions. These issues indicate a lack of control over critical manufacturing processes and quality systems.