Real Clean Distribuciones SA de CV – FDA Warning Letter, Jul 23, 2020

The FDA issued a Warning Letter to Real Clean Distribuciones SA de CV following the detention and refusal of Born Basic Anti-Bac Hand Sanitizer at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained an average of 45% ethanol and 24% methanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to active ingredient substitution with a dangerous chemical, and under 501(a)(2)(B) for demonstrating a failure in the firm's quality assurance and CGMP compliance. The product is also an unapproved new drug under section 505(a) as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. Furthermore, it is misbranded under sections 502(j), (a), (e), and (ee) because it is dangerous to health, falsely labeled regarding active ingredients, fails to list methanol, and does not comply with nonprescription drug marketing requirements under section 505G. The introduction of such adulterated and misbranded drugs into interstate commerce is prohibited. The FDA strongly recommends engaging a qualified CGMP consultant to evaluate operations and assist with corrective actions. All drugs manufactured by the firm were placed on Import Alert 66-78, subjecting them to detention without physical examination. The firm must respond within 15 working days detailing corrective actions and a completion schedule.