Warning Letter — Lico Industries, LLC., d.b.a. American Towelette Company
The FDA issued a Warning Letter to Lico Industries, LLC. (d.b.a. American Towelette Company) following an inspection by the Center for Drug Evaluation and Research (CDER).
This notice affects Lico Industries, LLC., and its quality, manufacturing, and regulatory departments responsible for oversight of drug product production.
The issuance of a Warning Letter by CDER suggests significant deviations from Current Good Manufacturing Practice (CGMP) regulations. This typically indicates that previous responses to inspectional observations were insufficient to address underlying compliance gaps, potentially leading to increased regulatory scrutiny or restrictions on product distribution until deficiencies are remediated.
Conduct a comprehensive review of CGMP compliance programs, focusing on laboratory testing protocols and facility maintenance. Firms should ensure that all finished products meet specifications prior to release and that manufacturing environments are appropriately controlled.
FDA Warning Letter issued to: Lico Industries, LLC., d.b.a. American Towelette Company. 07/30/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lico-industries-llc-dba-american-towelette-company-729921-07302026
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