Bionateo Sp. z.o.o.

Selected passages from the FDA letter

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

Passage 1

you have not provided FDA with all requested information, such as assay results and the specific testing methods used by your firm. Such testing and documentation thereof is required by 21 CFR 211.165.

Passage 2

FDA laboratory testing of a batch of this product detained at the border found that the drug product contained impurities at unacceptable levels. Methanol impurity levels were found to be between 625 ppm to 2,500 ppm. Testing also found approximately 0.88% (v/v) undeclared isopropanol in your hand sanitizer.

Passage 3

ALTAIO HAND SANITIZING GEL 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

It is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used according to its labeling as a hand sanitizer.

Passage 5

this 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 6

The failure of this product to list isopropyl alcohol and methyl alcohol (methanol) as ingredients on its label causes 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).

Passage 7

ALTAIO HAND SANITIZING GEL 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 8

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because ALTAIO HAND SANITIZING 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 of the FD&C Act, 21 U.S.C. 355.