FDA 483 - Biocon Limited - September 27, 2024

An FDA inspection of Biocon Limited in Bengaluru, India, revealed critical deficiencies across its quality systems, data integrity, cleaning validation, and production processes. The firm's quality unit failed to ensure adequate oversight and conduct scientifically sound investigations into OOS results and deviations, with some issues being repeat observations. Inadequate controls over computerized systems and cleaning validation protocols, along with poorly written batch manufacturing records, indicate a significant risk to the quality and consistency of APIs manufactured for the U.S. market.