FDA 483 - Biocon Limited - March 05, 2019

An FDA inspection of Biocon Limited, a non-sterile API manufacturer in Bangalore, India, revealed significant deficiencies across multiple areas. Observations included discrepancies between submitted drug master file information and actual manufacturing processes, inadequate bacterial endotoxin testing and environmental monitoring, and failures in laboratory controls regarding chromatographic data and equipment calibration. Additionally, the quality unit failed to investigate a critical process deviation.