Mumbai, Sept. 5 -- 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 comp...