USFDA concludes inspection at Biocon Biologics Bengaluru facilities
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.
At the conclusion of the inspection, the FDA issued a Form-483 with observations that can be broadly categorized as: one (1) observation across the four Drug Substance facilities; seven (7) observations across the two Drug Product facilities; two (2) observations on the Analytical Quality Control Laboratories; zero (0) observations on the Microbiology Laboratories; and zero (0) observations on the Warehouse operations.
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