By: IPP Bureau
Last updated : May 06, 2026 7:50 am
The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
Biocon Biologics has announced that the U.S. Food and Drug Administration completed a Pre-License Inspection (PLI) at its biosimilars manufacturing facility located at Biocon Park in Bengaluru, India.
The inspection was conducted from April 20 to April 29, 2026, covering three biologics manufacturing units, five quality testing laboratories, and two warehouses.
At the conclusion of the inspection, the US FDA issued a Form 483 with five observations. The company clarified that the observations are procedural in nature and are not related to data integrity or quality oversight issues. It also noted that there were no repeat observations during the inspection.
Biocon Biologics said it will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and remains confident that all observations will be addressed promptly and comprehensively.
The company further reiterated its commitment to maintaining the highest standards of quality and compliance while continuing to collaborate with global regulatory authorities to ensure the safety, efficacy, and reliability of its products.