FDA WARNING_LETTER - Alchymars ICM SM Private Limited - December 04, 2025

The FDA issued a warning letter to Alchymars ICM SM Private Limited following an inspection of its manufacturing facility in Tamil Nadu, India, conducted from November 28 to December 4, 2025. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering the products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included a failure to maintain manufacturing equipment and the facility building. Investigators discovered cracked gaskets, rust-like residues on product-contact surfaces, and inaccurate maintenance records that falsely claimed equipment was in good condition. Additionally, the facility suffered from severe leaks, with water dripping from the ceiling and machinery onto production floors, which the company attempted to manage using temporary barriers like plastic sheeting and drums. The FDA found the company’s initial response inadequate as it failed to assess the impact on product quality or explain the lack of quality unit oversight.

As a result, the FDA placed the firm on Import Alert 66-40 on May 19, 2026. To resolve these issues, Alchymars must provide a comprehensive corrective and preventive action (CAPA) plan, perform chemical and microbiological testing on retain samples for all products distributed to the United States, and document all physical repairs. The FDA also strongly recommends hiring a qualified consultant to conduct a full six-system audit of the facility’s operations. A formal response is required within 15 working days.