FDA Grants VAI Status to Biocon’s Biologics Facilities, Reflecting Compliance

The U.S. FDA has classified Biocon Biologics' facilities at Biocon Park in Bengaluru, India, as "Voluntary Action Indicated" (VAI) after conducting a thorough cGMP and Pre-Licensing Inspection (PLI) in July 2024. This inspection covered multiple biologics manufacturing units, including four drug substance and two drug product plants, as well as multiple quality control and microbiology laboratories and warehouses.

The VAI status indicates that, while minor observations were noted, they do not require further regulatory action by the FDA. Biocon Biologics reaffirmed its dedication to meeting global quality and compliance standards across its operations.