The U.S. Food and Drug Administration (FDA) conducted a cGMP inspection at Biocon Biologics’ Insulins Manufacturing Facility in Malaysia between September 17 - 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.

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 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.