Biocon Receives FDA Form 483 with Five Observations

U.S. FDA completed a Pre-License Inspection at Biocon's Bengaluru biosimilars site from April 20-29, 2026.
The inspection covered 3 biologics manufacturing units, 5 quality labs, and 2 warehouses.
FDA issued Form 483 with five procedural observations, excluding data integrity or quality oversight issues.
Biocon will submit a comprehensive CAPA plan to address all observations within the stipulated timeline.