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GuangZhou YouXing Cosmetic Co., Ltd manufactured V&W ADVANCE HAND SANITIZER REFRESHING GEL, an unapproved drug product that was detained at the U.S. border for failing to meet specifications. FDA laboratory testing revealed the hand sanitizer was adulterated due to subpotency (strength, purity, or quality below labeled claims) and demonstrated failures in the company's quality assurance and Current Good Manufacturing Practice (CGMP) systems. The product also violated regulations as an unapproved new drug and misbranded product introduced into interstate commerce without required FDA approval.