FDA WARNING_LETTER - AriBio H&B Co., Ltd. - October 19, 2021

The FDA issued a Warning Letter to AriBio H&B Co., Ltd., a human drug manufacturer in South Korea, following the detention and refusal of admission of their "Hand Sanitizer Original" product into the U.S. The FDA's laboratory testing revealed the product, labeled to contain 70% w/v anhydrous ethanol, only contained an average of 58% w/v ethanol, falling below the declared strength and the CDC's recommended minimum of 60% for effective hand sanitizers. This renders the product adulterated under section 501(c) of the FD&C Act.

Furthermore, the subpotency and deficiencies in the firm's response to requested information during a November 20, 2020 teleconference indicate that the quality assurance system is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements, leading to adulteration under section 501(a)(2)(B). The firm failed to provide documentation for methanol content testing or a scientific rationale for their ethanol content test method, violating 21 CFR 211.84 regarding raw material testing.

The product is also misbranded under sections 502(a) and (x) of the FD&C Act. The label falsely claims the product is a "Dietary Supplement" despite its intended use as a topical antiseptic, and it fails to disclose a domestic address or telephone number for reporting serious