FDA 483 - Biocon Biologics Limited

An FDA inspection of Biocon Biologics Limited in Electronics City Bengaluru, India, revealed significant deficiencies across multiple systems. The firm failed to establish and follow adequate procedures for facility maintenance, equipment cleaning, and quality control investigations. These issues included unsanitary manufacturing areas, rusted equipment, insufficient investigation into microbial contamination, and a lack of proper documentation for equipment repairs and laboratory errors, indicating a systemic breakdown in GMP compliance.