Jose Miguel Gutierrez Salas – FDA Warning Letter, Jul 21, 2022

The FDA issued a Warning Letter to Jose Miguel Gutierrez Salas (FEI 3016833431) in Tepic, Mexico, on July 21, 2022, following the detention and refusal of MVP Sanitizing Services SPRAY HAND SANITIZER at the U.S. border. FDA testing revealed the product, labeled to contain ethanol, instead contained 0% ethanol and an average of 63% methanol, a toxic substance.

This constitutes several violations: 1. **Adulteration:** The product is adulterated under 21 U.S.C. 351(d)(2) due to the substitution of ethanol with methanol, and under 21 U.S.C. 351(a)(2)(B) indicating a failure in Current Good Manufacturing Practice (CGMP) quality assurance. 2. **Unapproved New Drug:** The hand sanitizer is an unapproved new drug under 21 U.S.C. 355(a) as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It does not conform to any applicable Tentative Final Monograph (TFM) or temporary FDA policies, notably containing undeclared methanol and impermissible active ingredients (deionized water, glycerin, emollients). 3. **Misbranding:** The product is misbranded under 21 U.