FDA WARNING_LETTER - AHC Products Inc - October 23, 2025

The FDA issued a warning letter to AHC Products, Inc. following an inspection of its Winchester, Kentucky facility in October 2025. The inspection revealed major violations of federal drug manufacturing regulations and the Food, Drug, and Cosmetic Act. Central to the findings was the company’s failure to conduct proper laboratory testing; products were released based on visual color comparisons rather than scientific analysis, and some quality reports contained unsubstantiated data regarding heavy metals and microbes. Additionally, AHC Products failed to verify the identity of raw materials before production and did not validate its manufacturing processes. This lack of oversight led to significant inconsistencies in the strength of finished products. The FDA also noted that several items, such as AniPrin P and Rot-B-Gone, were marketed as unapproved new animal drugs, lacking the necessary safety and efficacy authorizations. Furthermore, the firm’s stability program was inadequate, as evidenced by missed testing dates and the distribution of products without expiration dates. To rectify these issues, AHC Products must engage an independent consultant to conduct a comprehensive audit of its six main operational systems. Within 15 working days, the company is required to submit a detailed remediation plan, including updated testing protocols and a risk assessment for products already on the market. Failure to comply could lead to legal consequences, including product seizures or manufacturing injunctions.