FDA WARNING_LETTER - Marco Antonio Rodriguez Fierro - March 09, 2021

The FDA issued a Warning Letter to Rodriguez Fierro, Marco Antonio, a Mexican human drug manufacturer, after their NATURAL GOLD GEL ALCOHOL ANTISEPTIC 75% Topical Solution hand sanitizer was detained at the U.S. border. FDA testing found the product, labeled for 75% v/v ethanol, contained only 31% v/v. This subpotency makes the drug adulterated under section 501(c) of the FD&C Act, as its strength is below representation. It also indicates quality assurance failures inconsistent with Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B). The product is an unapproved new drug, violating section 505(a) and 301(d) of the FD&C Act, lacking GRASE status and FDA approval. It fails to conform to the 1994 Tentative Final Monograph or meet section 505G(a)(3) conditions for marketing without approval. Furthermore, it is misbranded under section 502(a) due to false labeling regarding ethanol concentration, and under section 502(ee) for non-compliance with section 505G requirements for nonprescription drugs. The FDA strongly recommends engaging a qualified CGMP consultant. The firm must investigate the subpotency, provide raw material lists, batch records, and a reconciliation of all U.S.-distributed products. All firm products are on Import Alert 66-78, subject to detention. A response detailing corrective actions is required within 15 working days.