FDA Issues Warning Letter to Utah OTC Drug Manufacturer for Major GMP Violations

On 25 June 2025, the U.S. FDA issued a Warning Letter to Nature’s Fusions LLC, citing serious Current Good Manufacturing Practice (CGMP) breaches found during a January 2025 inspection of its Utah facility. The company repackages and manufactures OTC drug products.

Key violations included the absence of stability studies, arbitrary expiry dating, and improper storage of ethanol-based products outdoors since 2020 under uncontrolled temperatures. The firm failed to test incoming raw materials, relying solely on unverified supplier certificates, and released finished products without adequate chemical or microbial analysis. Additionally, the water system was unvalidated, with microbial levels exceeding acceptable limits.

The FDA noted these deficiencies reflect a lack of manufacturing control and raise significant product quality and safety concerns. The company has since ceased drug production and indicated it will not renew its OTC registration. FDA advised engaging a qualified GMP consultant before any market re-entry.

11-08-2025