FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - November 01, 2019

Megsan Labs Private Limited, a contract testing laboratory in Hyderabad, India, was cited for significant deficiencies in its laboratory control mechanisms and personnel adequacy. The inspection revealed failures in contemporaneous documentation, including blank spaces in records, missing signatures, and incomplete information for reagents and standards. Additionally, the firm was found to have an inadequate number of qualified personnel, leading to a high percentage of late samples in their LIMS.