DongBang 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

FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 55% w/w ethanol.

Passage 2

the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Passage 3

MISSY KAY Premium Hand Sanitizer is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a)

Passage 4

MISSY KAY Premium Hand Sanitizer is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is false or misleading.

Passage 5

MISSY KAY Premium Hand Sanitizer is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because it fails to comply with 21 CFR 201.15(c)(2), which states “if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.”

Passage 6

MISSY KAY Premium Hand Sanitizer is misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x), because the product label fails to disclose a complete domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.

Passage 7

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because MISSY KAY Premium Hand Sanitizer is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355G, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C.

Passage 8

the label of MISSY KAY Premium Hand Sanitizer states that it “sterilizes and disinfects hands and skin,” which suggests it is a disinfectant.