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  5. Jose Miguel Gutierrez Salas - 609983 - 07/21/2022
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WARNING LETTER

Jose Miguel Gutierrez Salas MARCS-CMS 609983 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Dionisio Martinez
Jose Miguel Gutierrez Salas

Calle Higuera 66
63174 Tepic, Nay.
Mexico

dmartinez20610@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Warning Letter 320-22-22

July 21, 2022

Dear Mr. Martinez:

The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as MVP Sanitizing Services SPRAY HAND SANITIZER. This drug product was declared to be manufactured at your facility, Jose Miguel Gutierrez Salas, FEI 3016833431, at Calle Higuera 66, Tepic, Mexico. Following an attempt to import MVP Sanitizing Services SPRAY HAND SANITIZER into the United States, it was detained and refused admission at the border.

The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product declared to be manufactured at your facility is adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), 21 U.S.C. 351(d)(2), in that a substance was substituted wholly or in part therefor. In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

In addition, 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), and is misbranded under sections 502(j), (a), (e)(1)(A), and (ee) of the FD&C Act, 21 U.S.C. 352(j), (a), (e)(1)(A) and (ee). Introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Furthermore, 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.

In addition, 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). Failure to register an establishment as required by section 510(i) or failure to properly list a drug as required by section 510(j) is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, under section 502(o) of the FD&C Act, 21 U.S.C. § 352(o), the failure to register an establishment or failure to list a drug renders a drug misbranded.

Adulteration Violations

MVP Sanitizing SPRAY HAND SANITIZER, declared to be manufactured at your facility, is labeled to contain the active ingredient alcohol (ethanol). However, 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.

Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects. Skin exposure to methanol can cause dermatitis, as well as transdermal absorption with systemic toxicity. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

While the contaminated drug product detailed above was shipped to the United States, information available to FDA demonstrated that all of your hand sanitizers were detained and refused admission at the border and did not enter the United States. Therefore, FDA did not recommend that you remove this product from the market. On August 19, 2020, FDA notified the public of the methanol contamination of your hand sanitizer drug products at the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

In response to this letter provide the following:

  • A detailed investigation into how the drug product described above, which was declared as manufactured at your facility and which was labeled as containing ethanol, was substituted in part or in whole with methanol;
  • A list of all raw materials used to manufacture all of your hand sanitizer drug products, including the suppliers’ names, addresses, and contact information;
  • A list of all batches of any hand sanitizer drug products shipped to the United States by your firm, and a full reconciliation of all material you distributed;
  • Copies of the complete batch records for all batches distributed to the U.S.;
  • Full formulation for your hand sanitizer drug products including the target ethanol content.

The substitution and contamination with methanol in a drug product declared as manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.1

Unapproved New Drug and Misbranding Violations

MVP Sanitizing Services SPRAY HAND SANITIZER is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), and because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a consumer topical antiseptic.

Examples of claims observed on the product label and labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:

“HAND SANITIZER . . .. . . DRUG FACTS . . . Uses: for hand washing to decrease bacteria on skin . . . Directions: spray on palm, rub hands together”2

This topical antiseptic product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below), or under other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your MVP Sanitizing Services SPRAY HAND SANITIZER drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, 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).

We note that over-the-counter (OTC) topical antiseptic products had been the subject of rulemaking under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by the “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub.

Additionally, OTC consumer antiseptic washes were addressed in “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Proposed Rule, 78 FR 76444 (December 17, 2013) (Consumer Antiseptic Washes Proposed Rule) and OTC Safety and Effectiveness of Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Final Rule, 81 FR 61106 (September 6, 2016). We note that ethyl alcohol is not one of the active ingredients that was classified as Category III for use as an active ingredient in a consumer antiseptic wash. Under the Consumer Antiseptic Washes rulemaking, ethyl alcohol was determined to be ineligible for evaluation under the OTC Drug Review for use as an active ingredient in consumer antiseptic washes.

Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.

However, MVP Sanitizing Services SPRAY HAND SANITIZER does not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, the 2013 Consumer Antiseptic Washes Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

As previously noted, statements on the MVP Sanitizing Services SPRAY HAND SANITIZER label suggest both that the product is a consumer antiseptic wash and that it is a consumer antiseptic rub. However, ethanol (in any concentration) is not an active ingredient permitted for use in consumer antiseptic hand washes under the 1994 TFM as amended by the Consumer Antiseptic Washes proposed rule. Furthermore, 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.

Additionally, according to the product label, MVP Sanitizing Services SPRAY HAND SANITIZER purportedly contains ethyl alcohol (ethanol). However, as previously discussed, 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.3

FDA laboratory analyses also demonstrated that a batch of MVP Sanitizing Services SPRAY HAND SANITIZER contains significant concentrations of the undeclared ingredient methyl alcohol (methanol). 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.4

Additionally, this methanol-containing drug product, MVP Sanitizing Services SPRAY HAND SANITIZER, is misbranded under sections 502(j), (a), (e)(1)(A), and (ee) of the FD&C Act, 21 U.S.C. 352(j), (a), (e)(1)(A) and (ee).

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. As previously stated, skin exposure to methanol could lead to systemic absorption, and substantial methanol exposure can potentially result in, among other things, blindness, permanent nervous system damage, and even death.

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.

Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that “in determining whether the labeling or advertising is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result . . .” Thus, the misleading representation that the product contains the active ingredient ethyl alcohol (ethanol), and the failure of the product label to disclose the presence of the methyl alcohol (methanol) in the product, causes this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

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).5

Lastly, 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.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Establishment Registration and Drug Listing Violations

Under section 510(i)(1) of the FD&C Act, 21 U.S.C. 360(i)(1), you are required to submit registration information annually by electronic means for each foreign establishment you own or operate engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States, and include the name of the United States Agent. As a drug manufacturer, it is your responsibility to ensure complete and accurate registration information. 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).

In addition, MVP Sanitizing Services SPRAY HAND SANITIZER and MVP Sanitizing Services HAND SANITIZER GEL are listed with FDA respectively under NDCs 76947-198 and 76947-199. While the drug listing data for these products include SNS Distribution LLC as the manufacturing establishment for this product, FDA’s import documents include Jose Miguel Gutierrez Salas, FEI 3016833431, at Calle Higuera 66, Tepic, Mexico as the manufacturing establishment. 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).

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations associated with your drug products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Note that FDA placed all drugs and drug products declared to be manufactured by your firm on Import Alert 66-78 on September 1, 2020, as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practice within the meaning of section 501(a)(2)(B) of the FD&C Act. Drugs and drug products that appear to be adulterated or misbranded may be detained or refused admission without physical examination.

All drugs and drug products manufactured by your firm may remain listed on this import alert until there is evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved, and the Agency has confidence that future entries will be in compliance with the FD&C Act. This may include an inspection prior to the Agency considering the appearance of adulteration to be addressed.

If you decide you want to manufacture drugs for the United States in the future, request a Regulatory Meeting to discuss corrective actions.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot do so within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov

Please identify your response with FEI 3016833431 and ATTN: Christina Capacci-Daniel.

Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

CC:
Importer:
SNS Distribution LLC
3380 W Ledbetter Drive
Dallas, TX 75233

_______________________

1 We note that your drug product also did not conform to any temporary policy FDA had implemented during the public health emergency. In March 2020, the Agency published three guidance documents to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). On December 31, 2021, these guidances were withdrawn, and firms must have ceased distribution, by March 31, 2022, of any remaining hand sanitizer products that were prepared under the temporary policies. See, 86 FR 56960, October 13, 2021.

2 We note that your MVP Sanitizing Services SPRAY HAND SANTIZER labeling contains conflicting information regarding whether it should be used as a consumer antiseptic wash or a consumer antiseptic rub. The term “hand sanitizer” generally refers to consumer antiseptic rubs, and the label of your product both indicates that the product is to be used for hand washing (presumably with water) and suggests that it should be used without water (i.e. “Spray on palm, rub hands together”). The MVP Sanitizing Services SPRAY HAND SANTIZER product, however, does not conform to the requirements for either a consumer antiseptic rub or a consumer antiseptic wash, as further described below.

3 The 1994 TFM, which does not distinguish between antiseptic hand washes and rubs, proposed for antiseptic hand washes and healthcare personnel hand washes an alcohol concentration of 60 to 95% by volume in an aqueous solution: 59 FR 31442. Later amendments to the 1994 TFM distinguished between antiseptic hand washes and rubs, and between consumer and healthcare personnel antiseptics, but did not change the alcohol concentration originally proposed in 1994.

4 An inactive ingredient used in OTC monograph drugs must meet the requirements of 21 CFR 330.1(e), which requires, among other things, that inactive ingredients must be safe in the amount administered.

5 Under 21 CFR 201.66(c)(2), “unless otherwise provided in an applicable OTC drug monograph or approved drug application, products marketed without discrete dosage units (e.g., topicals) shall state the proportion (rather than the quantity) of each active ingredient.”

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