FDA 483 - MMC HEALTHCARE LTD. - March 30, 2024

NMC HEALTHCARE LTD. in Chennai, India, was inspected by the FDA from March 25-30, 2024, as a drug manufacturer. The inspection revealed significant deficiencies across quality, production, laboratory, and facility systems, including critical data integrity issues, lack of proper process validations, inadequate laboratory controls, and basic facility shortcomings. These observations indicate a severe lack of adherence to cGMPs, posing potential risks to drug product quality and patient safety.