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Talk to a SpecialistTalk to a SpecialistMarco Antonio Rodriguez Fierro, a human drug manufacturer in Mexico, was cited for manufacturing NATURAL GOLD GEL ALCOHOL ANTISEPTIC 75% Topical Solution, which was found to be adulterated, unapproved, and misbranded in violation of the Federal Food, Drug, and Cosmetic Act. FDA laboratory testing of a batch detained at the U.S. border revealed the product's strength, purity, or quality fell below labeled claims, and the subpotency demonstrated that quality assurance procedures were not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements. The product was also an unapproved new drug introduced into interstate commerce without the required FDA approval.