GuangZhou YouXing Cosmetic Co., Ltd – FDA Warning Letter, Oct 8, 2020

The FDA issued a Warning Letter to GuangZhou YouXing Cosmetics Co. LTD. on September 30, 2021, after laboratory testing revealed their V&W ADVANCE HAND SANITIZER REFRESHING GEL (240ml/8oz) was subpotent. The product, labeled to contain 75% v/v ethyl alcohol, was found to contain only an average of 35% v/v ethanol, leading to its detention and refusal of admission into the U.S. The FDA determined the product is adulterated under section 501(c) of the FD&C Act due to its subpotency and under section 501(a)(2)(B) because the subpotency indicates a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements. Additionally, the hand sanitizer is an unapproved new drug, marketed in violation of sections 505(a) and 301(d) of the FD&C Act, as it is not generally recognized as safe and effective (GRASE) and does not conform to applicable monographs or temporary COVID-19 policies. It is also misbranded under section 502(a) due to false and misleading labeling regarding its active ingredient concentration, and under section 502(ee) for failing to comply with marketing requirements for nonprescription drugs under section 505G. All drugs from the firm were placed on Import Alert 66-78. The firm must provide a detailed investigation into the subpotency, lists of raw materials and suppliers, a reconciliation of all distributed batches, and complete batch records within 15 working days. The FDA strongly recommends engaging a qualified CGMP consultant if the firm intends to resume manufacturing for the U.S. market.