Biocon: US FDA completes biosimilars site inspection with 5 observations
Biocon Ltd announced that the U.S. Food and Drug Administration (FDA) completed a Pre-License Inspection (PLI) at its biosimilars manufacturing site in Biocon Park, Bengaluru, India. The inspection, conducted from April 20 to April 29, 2026, covered three Biologics Manufacturing units, five Quality testing laboratories, and two Warehouses. At its conclusion, the U.S. FDA issued a Form 483 with five observations. Biocon clarified that these observations are procedural in nature, do not relate to data integrity or quality oversight, and there were no repeat observations. The company is committed to submitting a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident in addressing all observations expeditiously.
Key Highlights
- US FDA completed Pre-License Inspection at Biocon's Bengaluru biosimilars site.
- Inspection resulted in a Form 483 with five procedural observations.
- Observations do not pertain to data integrity or quality oversight.
- Company will submit a CAPA plan to address all observations fully.