FDA WARNING_LETTER - Spa De Soleil, Inc. - January 26, 2026

In a warning letter dated July 8, 2026, the FDA cited Spa De Soleil, Inc. for significant violations of Current Good Manufacturing Practice (CGMP) regulations following an inspection of their Sun Valley facility from January 20 to 26, 2026. These failures render the company’s over-the-counter drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues included a systematic failure to investigate microbiological and chemical out-of-specification results in the facility’s water system. The FDA found the system’s design fostered biofilm development and that the company continued using potentially contaminated water in production. Additionally, the firm failed to conduct identity testing on incoming raw materials, specifically neglecting to screen high-risk components like glycerin and ethanol for lethal contaminants such as diethylene glycol and methanol. Further violations involved a lack of manufacturing process validation, flawed microbiological testing methods, and a Quality Control Unit that failed to provide adequate oversight of production and contract laboratories. Because these represent repeat violations from a 2021 inspection, the FDA requires immediate action. Spa De Soleil must provide comprehensive risk assessments for all products currently in distribution, develop remediation plans for their water and quality systems, and submit validation reports for their manufacturing processes. The company must respond within 15 working days detailing their corrective actions to avoid potential legal action, including product seizures or injunctions.