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FDA Warning Letter Explorer
Drugs · Mar 31, 2021

Neoingenium Labs, SA de CV

10 extracted findings

FDA source excerpt, selected passage

this hand sanitizer drug product is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
this hand sanitizer drug product is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested.
02
the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
03
this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
04
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.
05
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.
06
The failure of this drug product to list methyl alcohol (methanol) 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).
07
Cleansepure is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear a complete statement of identity as required under 21 CFR 201.61.
08
this product is misbranded under section 502(b)(1) of the FD&C Act, 21 U.S.C. 352(b)(1), because the product label does not contain the name and place of business of the manufacturer, packer, or distributor.
09
this product 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 (as described in section 760 of the FD&C Act) may receive a report of a serious adverse event with such drug.
10
this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because cleansepure 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.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 330.1(e)21 CFR 201.12821 CFR 201.6121 CFR 330

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