U.S. Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at Biocon’s biosimilars site at Biocon Park in Bengaluru, India. The inspection was conducted between April 20, 2026, and April 29, 2026, and covered 3 Biologics Manufacturing units, 5 Quality testing laboratories and 2 Warehouses. 

At the conclusion of the inspection, the USFDA issued a Form 483 with five observations. These observations are procedural in nature and do not pertain to data integrity or quality oversight. There were no repeat observations noted. The Company will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident all observations will be addressed fully and expeditiously.

Biocon 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.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.