FDA Issues Warning Letter Over Critical Water System Failures at OTC Manufacturer

Following an inspection in March 2025, the US Food and Drug Administration (FDA) issued a Warning Letter to Acme United Corporation, a manufacturer of over-the-counter medicinal products, citing serious GMP violations. Central to the findings were major deficiencies in the company’s water system, which was found incapable of consistently supplying water of appropriate quality. The objectionable microorganism Burkholderia cepacia was repeatedly detected in the system, alongside microbiological results indicating biofilm formation. The FDA criticised the company for failing to promptly and thoroughly investigate out-of-limit results.

Although a new on-demand water system had been installed, the FDA identified design weaknesses, noting that non-recirculating systems increase stagnation and biofilm risk. The agency rejected the firm’s claim that antimicrobial formulations mitigated patient risk.

In addition, the FDA identified serious shortcomings in process validation, sterile manufacturing controls, and quality oversight, including the release of untested sterile batches. The FDA now requires extensive corrective actions, risk assessments, and potential recalls.

26-01-2026