Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011347036.
Violations2
Issue DateSep 30, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
GuangZhou YouXing Cosmetic Co., Ltd
Location
Mr. Lijuan Zhen
GuangZhou YouXing Cosmetic Co., Ltd
No. 14, Shuanghe 2nd Road
Changhong, Baiyun District
Guangxi Zhuangzuzizhiqu , 510440
China
FEI Number
3011347036
Country
China
Issue Date
September 30, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
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.
GuangZhou YouXing Cosmetic Co., Ltd FDA Warning Letter, September 30, 2021
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