FDA WARNING_LETTER - Guangdong Kemei Pharmaceutical Technology Co. Ltd. - January 15, 2021

The FDA issued a Warning Letter to Guangdong Kemei Pharmaceutical Technology Co. Ltd. on December 14, 2021, following the detention and refusal of admission of their IMC WASH-FREE HAND SANITIZER product into the U.S. The firm is registered as a human drug manufacturer.

FDA laboratory testing revealed the hand sanitizer, labeled to contain 75% ethyl alcohol, actually contained an average of 35% ethyl alcohol and 32% methanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient with methanol, a toxic substance. The substitution also indicates the firm's quality assurance system is not compliant with Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B).

Furthermore, IMC WASH-FREE HAND SANITIZER 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(j), (a), (e), (x), and (ee) because it is dangerous to health, its labeling is false or misleading regarding active ingredient concentration and undeclared methanol, it fails to list all ingredients, lacks a domestic contact for adverse events, and does not comply with nonprescription drug marketing requirements.

The FDA previously notified