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Talk to a SpecialistTalk to a SpecialistSck Zeta Dis Ticaret, Pazarlama Ltd. was cited for manufacturing NEUTREVO Instant Hand Sanitizer, an unapproved antiseptic hand sanitizer product that was adulterated due to substance substitution and failed quality assurance controls that did not meet Current Good Manufacturing Practice (CGMP) requirements. The product was detained and refused admission at the U.S. border following FDA laboratory testing, which revealed violations of the Federal Food, Drug, and Cosmetic Act including being an unapproved new drug and misbranded under multiple statutory sections. The company's quality assurance system was found to be non-compliant with CGMP standards, demonstrating inadequate controls over the manufacturing process.