Guangzhou Zhongkebaishi Health Industry Co., Ltd. – FDA Warning Letter, Apr 19, 2022

The FDA issued a Warning Letter to Guangzhou Zhongkebaishi Health Industry Co., Ltd. on April 19, 2022, following the detention and refusal of admission of their "Hand Sanitizer Gel" product at the U.S. border. FDA testing revealed the product, labeled to contain 75% ethanol, only contained an average of 51% ethanol, rendering it adulterated under 21 U.S.C. 351(c) for subpotency and 351(a)(2)(B) due to inadequate quality assurance and CGMP non-compliance.

The product is also an unapproved new drug, violating 21 U.S.C. 355(a), as it lacks FDA approval and does not conform to the Tentative Final Monograph for OTC topical antiseptics, which requires at least 60% alcohol. Furthermore, it is misbranded under 21 U.S.C. 352(a), (c), (x), and (ee) because of false labeling regarding ethanol concentration, unauthorized use of the "FDA" logo, non-compliant "Drug Facts" panel formatting (missing headings, extraneous information), and failure to disclose a complete domestic address or phone number for adverse event reporting.

The FDA noted a pattern of inadequate responses to information requests regarding CGMP operations, including lack of documentation for test methods, supplier information,