Qapel Medical Inc. – FDA 483, Aug 8, 2024

Biocon Biologics Limited received an FDA Form 483 following an inspection of its Bengaluru, India drug manufacturing facility from July 10 to July 21, 2023. The inspection identified six significant observations related to compliance with Current Good Manufacturing Practice (CGMP) regulations under 21 CFR.

Key issues included inadequate validation of aseptic and sterilization processes, with media fill studies that did not represent commercial batch sizes or durations, and a failure to investigate positive units. The firm also lacked appropriate controls over computerized systems, exhibiting shared user access for manufacturing equipment and unvalidated software, which could compromise data integrity and process control. Furthermore, Biocon Biologics failed to thoroughly investigate out-of-specification results and manufacturing deviations, indicating a lapse in quality control procedures. Test methods for drug products and in-process testing were not adequately validated. Personnel in aseptic processing areas were observed with exposed skin, posing a risk of microbial contamination. Finally, the company’s stability program for drug products was deemed insufficient, lacking critical quality attributes in testing and providing inadequate data to support assigned expiry dates.

These observations necessitate comprehensive corrective actions from Biocon Biologics to ensure compliance with FDA regulations and safeguard the quality and sterility of its drug products.