USFDA classifies Biocon Biologics Biocon Park Site in Bengaluru as VAI
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-11-11 06:03 GMT | Update On 2024-11-11 06:07 GMT
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Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (USFDA) 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 (6) separate Biologics manufacturing units comprising of four (4) Drug Substance and two (2) Drug Product manufacturing plants as well as five (5) Analytical Quality Control Laboratories, four (4) Microbiology Laboratories, and two (2) Warehouses.
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