The U.S. Food and Drug Administration (FDA) has concluded a Pre-License Inspection (PLI) at Biocon‘s biosimilars site located at Biocon Park in Bengaluru, India. The inspection, which took place from April 20, 2026, to April 29, 2026, included a thorough review of three biologics manufacturing units, five quality testing laboratories, and two warehouses.
Following the inspection, the U.S. FDA issued a Form 483 with five observations. These observations are procedural and do not relate to data integrity or quality oversight. Importantly, no repeat observations were identified during this inspection. Biocon has committed to submitting a comprehensive Corrective and Preventive Action (CAPA) plan within the required timeframe and is confident that all observations will be addressed fully and promptly.
Biocon continues to prioritise maintaining the highest standards of quality and compliance. The company is dedicated to working collaboratively with global regulatory agencies to ensure the safety, efficacy, and reliability of its products.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).