FDA 483 - Biocon Limited - June 21, 2024

Biocon Limited, a manufacturer in Paravada, India, was cited for four observations during an FDA inspection. The findings include inadequate cleaning validation procedures, failure to review critical system alarms, insufficient temperature mapping for drug product storage, and deficiencies in microbial enumeration test method verification. These issues indicate a lack of robust quality control and adherence to GMP standards.