FDA WARNING_LETTER - DDI Multinacional S.A. de C.V. - June 29, 2020

The FDA issued a Warning Letter to DDI Multinacional S.A. de C.V. following laboratory testing of its hand sanitizer drug products, EARTHS AMENITIES Hand Sanitizer and AGAVESPA skincare HAND SANITIZER, which were detained at the U.S. border. Testing revealed these products were adulterated under section 501(d)(2) of the FD&C Act because the labeled active ingredient, ethanol, was largely substituted with methanol, a dangerous chemical. This substitution also demonstrated a failure of the firm's quality assurance to meet Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B).

Furthermore, the products are unapproved new drugs, violating section 505(a), as they are not generally recognized as safe and effective (GRASE) and do not conform to applicable OTC monograph conditions, specifically regarding active ingredient concentration and the presence of methanol. The hand sanitizers are also misbranded under sections 502(j), (a), (e), and (ee) for being dangerous to health due to methanol, having false and misleading labeling, failing to list methanol as an ingredient, and not complying with nonprescription drug marketing requirements.

Despite FDA's recommendation in June 2020 to remove products from the U.S. market, the firm initially declined a recall. Consequently, all drugs from the firm were placed on Import Alert 66-78. The FDA strongly recommends engaging a qualified CGMP consultant to evaluate operations, conduct a comprehensive audit, and assess corrective actions. The firm must respond within 15 working days detailing actions taken to address these violations and prevent recurrence.