| The inspection took place over nine days, from August 26 to September 3, 2025. It covered several critical areas including drug substance manufacturing units, analytical quality control (QC) laboratories, microbiology laboratories, and warehouses.
At the conclusion of the inspection, the U.S. FDA issued a Form 483 citing five procedural observations. According to Biocon, these observations are not related to data integrity, systemic non-compliance, or quality oversight issues.
Biocon Biologics has stated that it will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeframe and expressed confidence in addressing all observations promptly and effectively.
Importantly, the company confirmed it does not anticipate any impact on the supply of its commercial products.
“Biocon Biologics remains committed to upholding the highest standards of quality and compliance,” the company said in a statement, adding that it continues to work collaboratively with global regulatory agencies to ensure the safety, efficacy, and reliability of its products.
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.
In its latest financial results, Biocon reported a 95.2% decline in consolidated net profit to Rs 31.40 crore despite a 15.8% jump in net sales to Rs 3,910.10 crore in Q1 FY26 compared to Q1 FY25.
Shares of Biocon rose 1.68% to Rs 362.90 on the BSE.
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