FDA WARNING_LETTER - Nutratech - October 15, 2025

The FDA issued a warning letter to Nutratech, LLC following an inspection of its Phoenix, New York facility conducted between September 22 and October 15, 2025. The inspection identified significant violations of the Federal Food, Drug, and Cosmetic Act and specific regulations regarding Current Good Manufacturing Practices (CGMP) for dietary supplements. These failures resulted in the company"s products being classified as adulterated and misbranded.

Key issues identified included poor employee hygiene, such as workers contacting ready-to-eat powders with bare arms and working while ill. The facility itself was found to be in disrepair, with visible dirt, cobwebs, and broken ceiling tiles in production areas. Investigators also noted that manufacturing equipment was unsanitary and encrusted with food residue. Additionally, Nutratech failed to establish necessary quality specifications for finished products, maintained incomplete production records, and neglected to properly investigate customer complaints. One product was specifically flagged for failing to declare a major food allergen on its label.

While Nutratech submitted several responses outlining intended corrective actions, the FDA determined these were insufficient because the company failed to provide documented evidence, such as cleaning logs, training records, or photographs of repairs. Nutratech is required to submit a written response within 15 working days detailing the specific steps taken to correct these violations and prevent their recurrence. Failure to address these concerns may lead to legal action, including product seizures or injunctions.