Lico Industries, LLC., d.b.a. American Towelette Company – FDA Warning Letter, Feb 19, 2026

Lico Industries, LLC, doing business as American Towelette Company, received an FDA warning letter following an inspection of its Mohave Valley, Arizona facility from February 17 to 19, 2026. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, which classifies the firm"s over-the-counter drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. The primary issues centered on the failure of the company’s quality department to exercise proper oversight. Specifically, the FDA documented serious data integrity lapses, including the backdating of quality labels, the use of correction fluid on official records, and missing documentation for manufacturing activities. Additionally, investigators found stagnant product residue in equipment tubing, indicating a failure to adequately clean and maintain filling lines. The company also utilized insufficient microbiological testing methods that were not validated for pharmaceutical use. To address these violations, the FDA requires a comprehensive remediation plan. Required actions include a thorough assessment of documentation practices, a retrospective evaluation of potential product contamination due to poor cleaning, and a management strategy to ensure data integrity. The FDA strongly recommends that the firm hire an independent consultant to assist in bringing the facility into compliance. Lico Industries must submit a written response within 15 business days outlining its corrective actions; failure to do so may result in legal consequences such as product seizures or injunctions.