Guangzhou Shiruoni Cosmetics Co., Ltd

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

IMPACTA HEALTH HAND SANITIZER declared to be manufactured at your facility, is labeled to contain 75% volume/volume (v/v) of the active ingredient isopropyl alcohol (IPA). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average 67% v/v ethanol and 0% IPA.

Passage 2

The substitution in a drug product declared as manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.

Passage 3

IMPACTA HEALTH HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your webpage misleadingly implies that IMPACTA HEALTH HAND SANITIZER is FDA approved. For example, the description of the product states “FDA-Approved Hand Sanitizer.” However, IMPACTA HEALTH HAND SANITIZER product is not the subject of an FDA-approved application.

Passage 4

according to the product label, IMPACTA HEALTH HAND SANITIZER purportedly contains the active ingredient Isopropyl Alcohol 75% v/v. However, FDA laboratory analyses of batches of this product demonstrated that IMPACTA HEALTH HAND SANITIZER does not contain a detectable concentration of isopropyl alcohol. Furthermore, analyses revealed that the product contained concentrations of the undeclared ingredient, ethanol at 66.9% v/v.

Passage 5

The failure of this drug product to list ethanol as an ingredient on its label also causes it to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C. 352(e)(1)(A).