JG Atlas Comercios, SA de CV – FDA Warning Letter, Nov 10, 2020

The FDA issued a Warning Letter to JG Atlas Comercios S.A. de C.V. (Trueno No. 871 Paraisos Del Colli, Zapopan, Mexico) on November 6, 2020, following the detention and refusal of their Sayab Antiseptic Hand Sanitizer at the U.S. border. The firm had recently registered as a human drug manufacturer.

FDA laboratory testing of four batches of Sayab Antiseptic Hand Sanitizer revealed significant adulteration. The product, labeled to contain 70% ethanol, was found to contain negligible ethanol (0.1% to 10% v/v) and high concentrations of methanol (57% to 68% v/v). Methanol is a toxic substance unsuitable for consumer antiseptics, posing risks of dermatitis, systemic toxicity, blindness, and death. This substitution renders the product adulterated under section 501(d)(2) of the FD&C Act and indicates a failure of the firm's quality assurance system under section 501(a)(2)(B) (CGMP violations).

Furthermore, Sayab Antiseptic Hand Sanitizer is an unapproved new drug under section 505(a) of the FD&C Act and is misbranded under sections 502(j), (a), (e), and (ee). It is not generally recognized as safe and effective