FDA WARNING_LETTER - Acme United Corporation - March 28, 2025

The FDA issued a Warning Letter to Acme United Corporation on October 10, 2025, following an inspection from March 18-28, 2025, at their Shelton, CT drug manufacturing facility. The letter outlines significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated under the Federal Food, Drug, and Cosmetic Act. The primary issue identified was the company"s failure to adequately design, control, and maintain its water system, which is used in manufacturing topical over-the-counter drug products. Investigators repeatedly found objectionable microorganisms, specifically *Burkholderia cepacia*, and "too numerous to count" results, indicating a recalcitrant biofilm. The firm also failed to conduct timely and comprehensive investigations into these out-of-limit microbiological results, including root cause and product impact assessments. The FDA deemed the company"s response, which cited low safety risk and antimicrobial effects, inadequate, emphasizing that such formulations do not substitute for CGMP. Concerns were also raised about the design of a newly installed on-demand, non-recirculating water system. Acme United Corporation is required to provide a comprehensive assessment and remediation plan for its water system, an independent assessment of the new system, and a robust ongoing control and monitoring program. They must also submit an updated risk assessment for all distributed drug products, an action plan for microbiological testing of retain samples, stability study data, and a summary of all new water system test results. Furthermore, a retrospective review of invalidated out-of-limit water test results and a comprehensive remediation plan for their Out-of-Specification/Out-of-Limit investigation systems are mandated.