FDA WARNING_LETTER - Ignacio Reyes Gonzalez - August 13, 2020

The FDA issued a Warning Letter to Ignacio Reyes Gonzalez (FEI 3016931251) on January 25, 2021, following the detention and refusal of admission of "MEDICALLY MINDED Hand Sanitizer Gel ANTIMICROBIAL FORMULA" at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained an average of 1.4% ethanol and 63% methanol, a toxic substance.

This constitutes several violations: - **Adulteration:** The product is adulterated under section 501(d)(2) of the FD&C Act due to the substitution of ethyl alcohol with methanol, and under 501(a)(2)(B) indicating a failure of the firm's quality assurance system to meet CGMP requirements. - **Unapproved New Drug:** The hand sanitizer is an unapproved new drug under section 505(a) as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It also does not conform to the conditions for marketing under section 505G, nor FDA's temporary policies for hand sanitizers during the COVID-19 pandemic, due to the methanol content and incorrect ethanol concentration. - **Misbranding:** The product is misbranded under sections 502(j), (a), (