FDA WARNING_LETTER - DeVere Manufacturing Inc. - June 04, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to DeVere Manufacturing Inc. following an inspection of its Janesville, WI, facility from June 2 to 4, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the company"s drug products adulterated. Key issues included the failure to establish and follow adequate written procedures for equipment cleaning, specifically using shared equipment for both drug products and industrial cleaning detergents, which poses a serious cross-contamination risk. Additionally, DeVere Manufacturing Inc. failed to conduct adequate finished product release testing for its hand sanitizer drug products, neglecting tests for active ingredient identity and strength, impurities, and objectionable microorganisms, especially for batches made with unsuitable water. The company also failed to perform proper identity testing on incoming components like ethanol and glycerin, and did not validate supplier test analyses, risking the presence of hazardous impurities. The FDA requires the company to confirm the discontinuation of drug manufacturing on shared equipment or provide a plan for dedicated equipment, conduct a risk assessment for all drugs previously made on shared equipment, implement improved cleaning procedures, establish comprehensive chemical and microbial specifications with testing for all distributed products, and ensure robust identity testing for all components.