Ardil Comercial S.R.L.

Selected passages from the FDA letter

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

Passage 1

In your response, you did not provide test methods for your incoming API or finished product to ensure appropriate identity test for IPA, as required under 21 CFR 211.84 and appropriate assay testing for finished product as required per 21 CFR 211.165.

Passage 2

The labeling for Alcohol Isopropilico Hand Sanitizer Limar is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because it is not labeled in accordance to 21 CFR 201.15. For example, the label does not include a “Drug Facts” panel in the Spanish language.

Passage 3

Alcohol Isopropilico Hand Sanitizer Limar 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 domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.

Passage 4

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because Alcohol Isopropilico Hand Sanitizer Limar 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 of the FD&C Act, 21 U.S.C. 355.

Passage 5

Thus, the misleading representations of the concentration of the active ingredient isopropyl alcohol on the Alcohol Isopropilico Hand Sanitizer Limar labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).