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ShangRao Chunyu Technology Co., Ltd. manufactured an antiseptic hand sanitizer product labeled as containing 75% ethanol that was found to contain only 58% ethanol when tested by FDA at the U.S. border. The subpotent product violated Current Good Manufacturing Practice (CGMP) requirements, demonstrating that the company's quality assurance procedures were not functioning adequately to ensure the strength, purity, and quality of finished pharmaceuticals. The batch was detained and refused admission into the United States due to these adulteration violations under sections 501(a)(2)(B) and 501(c) of the Federal Food, Drug, and Cosmetic Act.