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.

 An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. 

There were no observations related to Data Integrity or on Quality oversight at any of the facilities also, no repeat observations were noted by the agency during the inspection.

"Biocon Biologics will submit a comprehensive Corrective and Preventive Action (CAPA) plan to the agency and is confident of addressing these observations expeditiously. We do not expect the outcome of these inspections to impact the supplies of our commercial products. Biocon Biologics remains committed to global standards of Quality & Compliance and to serving patients across the world.” the Company Spokesperson said in a statement.

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