USFDA concludes inspection at Biocon Biologics Malaysia Insulins facility

Karnataka: Biocon Biologics has announced that the US Food and Drug Administration (USFDA) has completed a cGMP inspection at the Company's Insulins manufacturing facility at Johor Bahru, Malaysia.

The inspection was conducted from September 17, and September 27, 2024.

The inspection scope included a number of biologics manufacturing units comprising one Drug Substance and one Drug Product manufacturing units, one Medical Device Assembly unit, one Analytical Quality Control Laboratory, two Microbiological Control Laboratories and two Warehouses.

The inspection concluded with the issuance of a form 483 with observations broadly categorized as: five observations across the Drug Substance and Drug Product facilities; zero observations on the Medical Device Assembly unit; three observations on the Analytical & Microbiological Quality Control Laboratory; and zero 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, Systemic Deficiencies or Quality Oversight at any of the units, noted by the agency, during the inspection.

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

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Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.

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