FDA WARNING_LETTER - Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V. - August 31, 2020

The FDA issued a Warning Letter to Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V., a human drug manufacturer in Mexico, following the detention and refusal of their ARGENT Defense Group HAND SANITIZER product at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained an average of 0.07% ethanol and 66% methanol.

This constitutes several violations: 1. **Adulteration:** The product is adulterated under section 501(d)(2) of the FD&C Act due to the substitution of ethyl alcohol with methanol, a toxic substance. It is also adulterated under section 501(a)(2)(B) as the substitution indicates a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements. 2. **Unapproved New Drug:** The hand sanitizer is an unapproved new drug under section 505(a) of the FD&C Act because it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It does not conform to the applicable Tentative Final Monograph (TFM) or temporary FDA policies for hand sanitizers during the COVID-19 pandemic, specifically regarding active ingredient concentration and the presence of methanol. 3. **Misbranding:** The product is misbranded under sections