FDA WARNING_LETTER - Neoingenium Labs, SA de CV - September 11, 2020

The FDA issued a Warning Letter to a newly registered human drug manufacturer in Zapopan, Mexico, following the detention and refusal of admission of their "cleansepure" hand sanitizer product at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained only 9.6% ethanol and 58% 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 ethanol with dangerous methanol. It is also adulterated under section 501(a)(2)(B) due to quality assurance failures, indicating non-compliance with Current Good Manufacturing Practice (CGMP) requirements. - **Unapproved New Drug:** "cleansepure" 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 does not conform to the applicable Tentative Final Monograph (TFM) or temporary FDA policies for hand sanitizers. - **Misbranding:** The product is misbranded under multiple sections of the FD&C Act (502(j), (a), (e)(1)(A), (c), (x), (b)(1), and (ee)) because it is dangerous to health, its labeling is false/