FDA Inspection at Biocon Biologics Facility

The U.S. FDA completed a routine cGMP inspection at Biocon Biologics’ Bengaluru facility (Aug 26–Sept 3, 2025), issuing five procedural Form 483 observations. No data integrity or systemic issues were found. Biocon will file a CAPA plan promptly and expects no impact on product supply, reaffirming its quality and compliance commitment.