USFDA completes cGMP inspection at insulins manufacturing facility of Biocon’s arm

30 Sep 2024 Evaluate

The U.S. Food and Drug Administration (USFDA) has completed cGMP inspection at Biocon’s subsidiary -- Biocon Biologics’ insulins manufacturing facility in Malaysia. USFDA had conducted the said an inspection between September 17-27, 2024.

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.

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.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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