FDA WARNING_LETTER - Eskbiochem SA de CV - July 23, 2020

The FDA issued a Warning Letter to Eskbiochem SA de CV, a registered human drug manufacturer in Mexico, after its hand sanitizer products, ClearCare Nogerm ADVANCED HAND SANITIZER and LAVAR GEL HAND SANITIZER, were detained at the U.S. border. FDA testing revealed severe adulteration: products labeled to contain ethyl alcohol were substituted with significant concentrations of toxic methanol. For instance, LAVAR GEL contained 0% ethanol and 83% methanol instead of 70% ethanol. This substitution renders the products adulterated under FD&C Act sections 501(d)(2) and 501(a)(2)(B), indicating a critical failure in the firm's quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements.

Furthermore, these hand sanitizers are unapproved new drugs under section 505(a) and 201(p) because they are not generally recognized as safe and effective (GRASE), lack FDA approval, and do not conform to the applicable Tentative Final Monograph (TFM) or temporary COVID-19 policies. Their labeling includes exaggerated claims and falsely states "FDA Approved." The products are also misbranded under sections 502(j), (a), and (e) due to being dangerous to health, having false and misleading labels regarding active ingredients, and failing to declare methanol.

Eskbiochem is required to conduct a detailed investigation into the methanol substitution, provide comprehensive lists of raw materials, suppliers, and U.S.-shipped batches with full batch records, and undertake an independent assessment of its laboratory practices. A response detailing corrective actions is due within 15 working days. The firm's products are currently on Import Alert 66-78, and future shipments face refusal of admission. FDA may also withhold approval of new drug applications until compliance is verified.