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Guangzhou Minghui Cosmetics Co., Ltd. was cited for manufacturing Qi Yu® Hand Sanitizer Gel, an unapproved new drug that was adulterated and misbranded, with FDA laboratory testing revealing the product's active ingredient strength fell below labeled claims. The company's quality assurance and current good manufacturing practice (CGMP) controls were found to be inadequate, as evidenced by the subpotent batch detected during a border detention and refusal of admission. The product violated multiple sections of the Federal Food, Drug, and Cosmetic Act, including prohibitions on introducing unapproved new drugs into interstate commerce and misbranding requirements.