FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - September 23, 2022
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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.
ID · 8217694f-c9f0-438f-a259-1feab2ad57a6