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Talk to a SpecialistTalk to a SpecialistJose Miguel Gutierrez Salas manufactured MVP Sanitizing Services Spray Hand Sanitizer, an unapproved drug product that was detained at the U.S. border after FDA laboratory testing revealed it was adulterated due to substance substitution, indicating failure of quality assurance systems to comply with Current Good Manufacturing Practice (CGMP) requirements. The product also violated FDA regulations by being introduced into interstate commerce as an unapproved new drug and was misbranded under multiple sections of the Federal Food, Drug, and Cosmetic Act. The facility failed to maintain proper drug manufacturing controls and quality standards required for pharmaceutical products.