Biotechnology firm Biocon Limited on Thursday (September 4) said the US Food and Drug Administration (FDA) has completed a routine current Good Manufacturing Practice (cGMP) inspection at Biocon Biologics’ drug substance facility at its Biocon Campus in Bengaluru, India.
The inspection, conducted between August 26 and September 3, 2025, covered drug substance manufacturing units, analytical quality control laboratories, microbiology laboratories, and warehouses.
At the conclusion of the inspection, the FDA issued a Form 483 with five observations. Biocon said these observations are procedural in nature and do not relate to data integrity, systemic non-compliance, or quality oversight.
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The company added that Biocon Biologics will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident of addressing all observations expeditiously. It further stated that the inspection outcome will not impact the supply of its commercial products.
“Biocon Biologics remains committed to upholding the highest standards of Quality and Compliance, and working collaboratively with global regulatory agencies to ensure the safety, efficacy, and reliability of its products,” the company stated.
Shares of Biocon Ltd ended at ₹357.50, down by ₹4.05 or 1.12%, on the BSE today (September 4).
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