FDA WARNING_LETTER - Guangzhou Shiruoni Cosmetics Co., Ltd - December 17, 2020

The FDA issued a Warning Letter to Guangzhou Shiruoni Cosmetics Co., Ltd. (FEI 3014510437) on December 7, 2021, following the detention and refusal of admission of their "IMPACTA HEALTH HAND SANITIZER" product at the U.S. border. FDA laboratory testing revealed the product, labeled to contain 75% v/v isopropyl alcohol (IPA), actually contained 67% v/v ethanol and 0% IPA.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to active ingredient substitution, and under 501(a)(2)(B) due to a dysfunctional quality assurance system, indicating non-compliance with Current Good Manufacturing Practice (CGMP) requirements. The firm admitted not following 21 CFR Parts 210 and 211 regulations and failed to provide a Certificate of Analysis for ethanol or confirm finished product testing.

Additionally, the product is misbranded under sections 502(a) and 502(e)(1)(A) of the FD&C Act. Misbranding violations include false or misleading labeling, such as claiming "FDA-Approved Hand Sanitizer" when it is not, and misrepresenting the active ingredient as IPA while failing to declare the actual ingredient, ethanol. The firm's employees reportedly could not read English, hindering label