USFDA concludes inspection at Biocon Biologics Bengaluru facilities
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-07-29 07:23 GMT | Update On 2024-07-29 07:23 GMT
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Bengaluru: The U.S. Food and Drug Administration (USFDA) has concluded a combined cGMP inspection and PreLicensing Inspection (PLI) at Biocon Biologics' facilities at Biocon Park, Bengaluru, India.
The combined inspection was conducted between July 15, and July 26, 2024.
The inspection scope included six (6) separate Biologics manufacturing units comprising four (4) Drug Substance and two (2) Drug Product manufacturing plants. In addition, the inspection also covered five (5) Analytical Quality Control Laboratories and four (4) Microbiology Laboratories, and two (2) Warehouses.
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