Biocon Biologics Limited – FDA 483, Apr 29, 2026

Biocon Biologics Limited in Bengaluru, Karnataka, India, was cited for significant deficiencies during an FDA inspection of its drug substance and drug product manufacturing facility. The observations highlight severe issues with aseptic processing, including recurring microbial contamination and ineffective remediation efforts, as well as inadequate validation of aseptic and sterilization processes. Furthermore, the firm's quality system was found to be deficient in managing deviations, conducting timely investigations, and maintaining detailed batch records.