Loading…
Guangzhou Zhongkebaishi Health Industry Co., Ltd. was cited for manufacturing Hand Sanitizer Gel that failed FDA laboratory testing and was detained at the U.S. border. The product violated the Federal Food, Drug, and Cosmetic Act as an unapproved new drug that was adulterated due to subpotency (falling below represented strength, purity, or quality), misbranded, and manufactured without adequate quality assurance systems compliant with Current Good Manufacturing Practice (CGMP) requirements. The violations included failure to maintain proper manufacturing controls and quality standards required for pharmaceutical products intended for introduction into U.S. interstate commerce.