FDA WARNING_LETTER - JW Nutritional LLC - September 26, 2025

On April 15, 2026, the FDA issued a warning letter to JW Nutritional LLC following an inspection of its McKinney, Texas, facility from September 22 to 26, 2025. The inspection identified serious violations of Current Good Manufacturing Practice (CGMP) regulations, which are the federal standards for ensuring drug safety and quality. Under the Federal Food, Drug, and Cosmetic Act, the company’s over-the-counter drug products are considered contaminated because the manufacturing processes did not meet these requirements. The primary violations involved a failure to adequately test raw materials. Most notably, the company did not screen high-risk ingredients for hazardous contaminants like diethylene glycol, which can be lethal. Additionally, the firm failed to validate its manufacturing processes and its water system, which is used both for product formulation and cleaning. The FDA also noted that the company’s laboratory controls were insufficient, as they used food-grade microbiological standards rather than the stricter standards required for pharmaceuticals, allowing for much higher levels of bacteria and mold than are safely permitted. To address these issues, the FDA requires JW Nutritional LLC to perform a full risk assessment of its products, test retained samples for impurities, and provide a comprehensive plan for validating its equipment and manufacturing controls. The company must also overhaul its water monitoring and laboratory testing procedures. A written response detailing these corrective actions is required within 15 working days, or the company may face legal actions such as product seizures or injunctions.