MMC HEALTHCARE LTD. – FDA Warning Letter, Mar 30, 2024

On September 24, 2024, the FDA issued a Warning Letter to MMC Healthcare Ltd. following an inspection from March 25-30, 2024, at their Chennai, India drug manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under the FD&C Act.

Key violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The firm failed to establish an adequate quality control unit. Investigators found backdated signatures, added data, and replaced pages in process validation reports for 2021 (b)(4) Tablets and (b)(4) Capsules. Management admitted participation. The FDA deemed the firm's response inadequate for failing to assess the full extent of backdating and implement comprehensive corrective actions. 2. **Insufficient Computer System Controls (21 CFR 211.68(b)):** The UV-Vis spectrophotometer system, used for drug product release testing, lacked appropriate controls like audit trails and defined user access levels. The firm's proposed software update was deemed insufficient due to lack of detail on timeframe, security features, user access, and interim data integrity measures. 3. **Unvalidated Test Methods (21 CFR 211.165(e)):** The firm failed to establish the accuracy, sensitivity, specificity