Biocon Biologics announced on Saturday, September 28, that the US Food and Drug Administration (US FDA) has completed a Current Good Manufacturing Practice (cGMP) inspection of its Insulins Manufacturing Facility in Johor Bahru, Malaysia. The inspection, which took place between September 17 and September 27, 2024, covered multiple biologics manufacturing units and quality control laboratories.

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

The FDA has issued a Form 483 with five observations related to the Drug Substance and Drug Product facilities, three observations for the Analytical & Microbiological Quality Control Laboratories, and none for the Medical Device Assembly and Warehouse operations. The FDA did not raise concerns regarding Data Integrity, Systemic Deficiencies, or Quality Oversight during the inspection.

Biocon Biologics said it “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.”

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