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DMM Vission, S.A. de C.V., a Mexican drug manufacturer, was cited for producing unapproved hand sanitizer products (SYP HEALTH HAND SANITIZER ALCOHOL GEL and Cleaner BY CRYSTALWARE HAND SANITIZER) that were detained at the U.S. border. FDA laboratory testing found the products were adulterated due to substance substitution and demonstrated failure of quality assurance systems to comply with Current Good Manufacturing Practice (CGMP) requirements. The products violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including regulations prohibiting unapproved new drugs and misbranded products lacking proper labeling and approval.