Jose Miguel Gutierrez Salas

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 0% ethanol and an average of 63% methanol volume/volume. Therefore, 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.

Passage 2

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

Passage 3

MVP Sanitizing Services SPRAY 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

you have manufactured, prepared, propagated, compounded, or processed drugs that were being imported or offered for import into the United States, while your drug manufacturing facility, Jose Miguel Gutierrez Salas, FEI 3016833431, at Calle Higuera 66, Tepic, Mexico is not an FDA-registered establishment.

Passage 5

drugs you manufactured at this establishment are not listed as such with FDA, as required by section 510(j) of the FD&C Act, 21 U.S.C. 360(j).

Passage 6

the label for MVP Sanitizing Services SPRAY HAND SANITIZER states that it contains four active ingredients, as follows: “Active ingredients: Denatured ethyl alcohol, deionized water, glycerin, emollients.” Deionized water, glycerin, and emollients are not permitted active ingredients, either as sole ingredients or in combination with other ingredients like ethyl alcohol, for use in consumer antiseptic wash or consumer antiseptic rub drug products under the 1994 TFM.

Passage 7

FDA laboratory analysis of a batch of this product detained at the border demonstrated that MVP Sanitizing Services SPRAY HAND SANITIZER contains no traceable amounts of ethanol. Such a product does not conform with the 1994 TFM or the applicable requirements.

Passage 8

Use of methanol as an active ingredient is not in conformance with the 1994 TFM. Furthermore, methanol is not acceptable as an inactive ingredient in hand sanitizers. As previously discussed, methanol has significant and sometimes fatal toxic effects and, therefore, does not meet the requirements under 21 CFR 330.1(e) that a product’s inactive ingredients be safe and suitable.

Passage 9

MVP Sanitizing Services SPRAY HAND SANITIZER 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 10

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. As noted above, MVP Sanitizing Services SPRAY HAND SANITIZER is labeled to contain ethyl alcohol. However, FDA laboratory analysis of a batch of this product demonstrates that the product contains no traceable amounts of ethyl alcohol and a significant concentration of methyl alcohol (methanol), an ingredient that is not declared on the product label.

Passage 11

The failure of this 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). Further, this product is misbranded under 502(e)(1)(A) because the product does not list the proportion of each active ingredient, as required by 21 CFR 201.66(c)(2).

Passage 12

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because MVP Sanitizing Services SPRAY HAND SANITIZER 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 13

You have failed to fulfill your establishment registration obligations under section 510 of the FD&C Act, which is prohibited under section 301(p), 21 U.S.C 360 and 331(p). As a result, all drugs you manufacture in this establishment are misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

Passage 14

Failure to list these drugs with FDA with the correct manufacturing establishment as required by section 510 of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Failure to properly list a drug with the FDA will also render it misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).