By: IPP Bureau
Last updated : November 11, 2024 8:12 pm
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The U.S. Food and Drug Administration (FDA) has classified Biocon Biologics’ facilities at Biocon Park, Bengaluru, India, as Voluntary Action Indicated (VAI).
“This relates to the combined cGMP inspection and Pre-Licensing Inspection (PLI) conducted by the agency between July 15 – 26, 2024. The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants as well as five Analytical Quality Control Laboratories, four Microbiology Laboratories, and two Warehouses. Biocon Biologics remains committed to global standards of Quality and Compliance,” said a company spokesperson.