FDA 483 - Biocon Biologics Limited

An FDA inspection of Biocon Limited in Bangalore, India, a drug product manufacturer, revealed significant deficiencies in their aseptic processing procedures and environmental monitoring. Observations included inadequate written procedures for preventing microbial contamination, poor aseptic techniques by operators, and ineffective investigations into environmental monitoring excursions. These issues indicate a lack of control over critical aspects of sterile drug product manufacturing.