FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - July 15, 2016

Megan Labs Private Limited, a control testing laboratory in Hyderabad, India, was inspected by the FDA from July 13-15, 2016. The inspection revealed significant deficiencies in laboratory controls, including inadequate calibration procedures for testing equipment and a lack of scientific justification and defined protocols for out-of-specification (OOS) investigations and retesting. These issues indicate a failure to ensure the quality and purity of drug components and products.