FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - September 23, 2022

An FDA inspection of Megsan Labs Private Limited in Hyderabad, India, revealed three significant observations. The firm's quality control unit failed to follow written procedures, with issues such as non-working pressure gauges and inadequate controls for GMP data storage. Additionally, investigations into unexplained discrepancies lacked proper root-cause analysis and preventive actions, and laboratory control mechanisms showed deficiencies in contemporaneous documentation and record-keeping.