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Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, a Mexican drug manufacturer, was cited for manufacturing Pristine Hand Sanitizer Gel, an unapproved new drug that was adulterated and misbranded. FDA laboratory testing of a detained batch found the product was subpotent, demonstrating failures in quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements. The product violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including unauthorized introduction of an unapproved new drug into interstate commerce and improper labeling claims.