Guangzhou Zhongkebaishi Health Industry 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 51% volume/volume (v/v) ethanol. This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the product lower than that which is declared on its labeling.

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

you did not provide any documentation of your finished product test methods, analytical procedures, impurity testing, stability reports or batch records.

Passage 4

Without adequate testing of incoming raw materials and finished product, as required under 21 CFR 211.84 and 21 CFR 211.165 respectively, you cannot assure that your drug products conform to appropriate standards of identity, strength, quality and purity.

Passage 5

You explained this was a one-time accident but did not provide a detailed investigation.

Passage 6

this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act

Passage 7

the misleading representation of the concentration of the active ingredient ethanol on the Hand Sanitizer Gel labeling cause this product to be misbranded under section 502(a) of the FD&C Act

Passage 8

the “FDA” logo is displayed on the product principal display panel which creates the impression that the drug is approved or legally marketable (see 21 CFR 207.77(b)).

Passage 9

your product label fails to include headings for the Active ingredient(s) and Purpose(s), nor is the “Drug Facts” panel labeled, organized, or presented in accordance with 21 CFR 201.66(c). Therefore, this product is misbranded under section 502(c) of the FD&C Act

Passage 10

your Drug Facts panel contains a “Properties & Functions” section which includes extraneous statements such as "Leaves skin feeling soft, dry, and free."

Passage 11

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 12

Hand Sanitizer Gel is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505