FDA WARNING_LETTER - ALMON HEALTHCARE PRIVATE LIMITED - February 13, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Almon Healthcare Private Limited following an inspection of its manufacturing facility in Ahmedabad, India, from February 9 to 13, 2026. The inspection identified significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), resulting in the products being classified as adulterated under the Federal Food, Drug, and Cosmetic Act. A primary violation involved the Quality Unit intentionally accepting mislabeled raw materials to bypass licensing requirements, failing to perform necessary identity testing or supplier qualifications. This practice posed serious safety risks and demonstrated a systemic failure in quality oversight. Additionally, the firm failed to validate analytical test methods, rendering them unable to accurately detect impurities or support product stability claims. Investigators also found visible residues on equipment documented as clean, indicating inadequate cleaning procedures and a lack of validation to prevent cross-contamination. Consequently, the FDA placed the firm on an import alert in June 2026. To address these issues, the company must provide a comprehensive remediation plan for its Quality Unit, conduct an independent assessment of laboratory practices, and perform a retrospective review of cleaning effectiveness. The FDA also recommends hiring a qualified consultant to assist in bringing the facility into compliance. A detailed response is required within 15 working days.