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Talk to a SpecialistTalk to a SpecialistDongBang Cosmetics Co., Ltd. was warned for manufacturing MISSY KAY Premium Hand Sanitizer, an unapproved new drug that was adulterated and misbranded in violation of federal law. FDA laboratory testing of a batch detained at the U.S. border found the product's active ingredient alcohol content fell below the labeled 62% w/w concentration, demonstrating subpotency and a failure of quality assurance systems to meet Current Good Manufacturing Practice (CGMP) requirements. The product violated multiple sections of the Federal Food, Drug, and Cosmetic Act, including those prohibiting unapproved new drugs and misbranded products from being introduced into interstate commerce.