DongBang Cosmetics Co., Ltd. – FDA Warning Letter, Nov 2, 2021

The FDA issued a Warning Letter to DongBang Cosmetics Co., a human drug manufacturer, following the detention and refusal of admission of their "MISSY KAY Premium Hand Sanitizer" into the U.S. due to quality and regulatory violations.

FDA testing revealed the hand sanitizer, labeled to contain 62% w/w ethanol, only contained an average of 55% w/w, 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. The subpotency also indicates a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B).

Furthermore, the product is an unapproved new drug, violating section 505(a), as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It is also misbranded under sections 502(a), (c), (x), and (ee) because of false labeling regarding ethanol concentration, failure to include all required information in foreign languages present on the label, absence of a complete domestic address or phone number for adverse event reporting, and non-compliance with section 505G for nonprescription drugs.

The firm failed to provide adequate or complete responses to FDA's requests for