FDA WARNING_LETTER - UMENDRA LIFE SCIENCES PRIVATE LIMITED - August 01, 2025

On June 2, 2026, the FDA issued a warning letter to Umendra Life Sciences Private Limited following a review of manufacturing records requested in August 2025. The agency determined that the company’s over-the-counter (OTC) drug products are adulterated due to significant violations of Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act. A primary concern is the firm’s failure to establish adequate quality control oversight, particularly regarding the testing of talc for asbestos contamination. Asbestos is a known carcinogen, and the FDA highlighted that products intended for inhalation or use in sensitive areas pose a high risk to patient safety. The investigation revealed that the company did not use scientifically sound methods to verify the identity and purity of raw materials, often relying on supplier certificates of analysis that were not properly validated or compliant with United States Pharmacopeia (USP) standards. Additionally, the company failed to provide sufficient oversight of its contract testing laboratories. To address these violations, the FDA requires Umendra Life Sciences to submit a comprehensive remediation plan for its quality unit, perform a retrospective risk assessment for products currently on the market, and conduct asbestos testing on all retained component samples. The firm must also provide an update on its reported transition to talc-free formulations and respond in writing within 15 working days to detail its corrective actions.