FDA WARNING_LETTER - SURETEC INNOVATIONS LLC - March 05, 2026

Following an inspection from March 2 to 5, 2026, the FDA issued a warning letter to Suretec Innovations, LLC, regarding significant manufacturing and quality control violations at its Gilbert, Arizona facility. The agency determined that the company’s drug products were manufactured under conditions that failed to meet Current Good Manufacturing Practice (CGMP) standards, violating the Federal Food, Drug, and Cosmetic Act. Key violations included the failure to test raw materials and active ingredients for identity and purity, relying instead on unverified supplier reports. The company also lacked valid microbiological testing methods for finished products and failed to investigate high bacterial counts found in the water system used for production. Furthermore, the Quality Control Unit failed to exercise proper oversight regarding production processes, stability testing, and personnel qualifications. In addition to these manufacturing issues, the FDA identified drug listing violations, specifically regarding the failure to register "KleenLine Alcohol-Free Sanitizing Wipes," which led to the product being classified as misbranded. The FDA has required Suretec to hire an independent consultant to evaluate their operations and perform a comprehensive audit. The company must also provide a detailed remediation plan, conduct retrospective testing on distributed products, and respond to the agency within 15 working days. Failure to address these deficiencies may result in legal actions such as product seizures or injunctions.