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  5. Inovaker Lab S.A. de C.V. - 609979 - 02/25/2021
  1. Warning Letters

WARNING LETTER

Inovaker Lab S.A. de C.V. MARCS-CMS 609979 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Victor Manuel Escarcega Gomez
Recipient Title
CEO
Inovaker Lab S.A. de C.V.

Luis Quintanar Poniente 1105 Bella Vista
64410 Monterrey, N.L.
Mexico

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Warning Letter 320-21-29


February 25, 2021

Dear Mr. Gomez:

Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a topical antiseptic drug product labeled as Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution. This drug product was labeled as and declared to be manufactured at your facility, Inovaker Lab S.A. de C.V., FEI 3009028673 at Luis Quintanar Poniente 1105 Bella Vista, Monterrey, Nuevo Leon. Following an attempt to import Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution into the United States, it was detained and refused admission at the border.

The results of the FDA laboratory testing of a batch of the product detained at the border demonstrate that the Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution drug product, labeled as and declared to be manufactured at your facility, is adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c), in that its strength, purity, or quality falls below that which it purports or is represented to possess. In addition, this product is adulterated within the meaning of section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), in that the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

In addition, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution 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 misbranded under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee). Introduction or delivery for introduction of such 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.

Adulteration Violations

Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, labeled as and declared to be manufactured at your facility, is labeled to contain 75% volume/volume (v/v) of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained no ethanol or 0% v/v. This topical antiseptic drug product is adulterated under section 501(c) of the Act in that the active ingredient of ethanol is not present and this product does not contain the active ingredient declared on its labeling.

CDC recommends1 that, if soap and water are not readily available, consumers use an alcohol-based hand sanitizer that contains not less than 60% alcohol (ethanol). This is the minimum active ingredient concentration of ethanol specified in the 1994 Tentative Final Monograph for Health-Care Antiseptic Drug Products (59 FR 31402), 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). The observed lack of active ingredient in your product is of particular concern because this product is labeled for use as a “health care personnel hand rub”.

On September 23, 2020, FDA held a teleconference with you and your registered U.S. Agent, Fiesta Union LLC. We recommended you consider initiating a recall of all hand sanitizer drug products currently in distribution in the U.S. market. However, as of the date of this letter you have yet to initiate a recall. On October 13, 2020, you informed FDA that you did not recognize this import and believed your business identity was being used by another party.

On September 24, 2020, FDA notified the public of the subpotency of your topical antiseptic 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 labeled as and declared to be manufactured at your facility, and which was labeled as containing 75% v/v ethanol, in fact contained 0% ethanol.

• A list of all raw materials used to manufacture your topical antiseptic drug products, including the suppliers’ names, addresses, and contact information.

• A list of all batches of any topical antiseptic drug products (including products labeled as containing ethanol or isopropanol (isopropyl alcohol) as the active ingredient) shipped to the United States, and a full reconciliation of all material you distributed.

• Copies of the complete batch records for all topical antiseptic drug product batches (including products with ethanol or isopropyl alcohol as the active ingredient) distributed to the U.S.

• During the teleconference with FDA on September 23, 2020, you stated that your topical antiseptic drug product batches are tested and must meet specifications prior to release.

o Provide the tests, test methods, and specifications for Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution and all other topical antiseptic products that have been imported into the US, including products labeled as isopropyl alcohol based hand sanitizers. State which tests are performed by your facility. If any testing is performed by contract laboratories, provide the name of the outside laboratories, their address, and the testing they perform.
o Provide the drug product release testing results for all batches of topical antiseptic drug products (including products labeled as ethanol or isopropyl alcohol based hand sanitizers) imported into the US or offered for import, including the batches in entry (b)(4) submitted for import on (b)(4).

The subpotency of topical antiseptic drug product labeled as and declared to be 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.2

Unapproved New Drug and Misbranding Violations

Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution 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), because it is intended to affect the structure or any function of the body. Specifically, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution is intended for use as a topical antiseptic.

Examples of claims observed on the Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution product label 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 . . . Purpose Antiseptic . . . Use(s) Health care personnel hand rub to help reduce bacteria that potentially can cause disease.”

“Direction. . .Place enough product on hands to cover all surfaces. Rub hands together until dry.”3

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 Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution 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 FDA’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 “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; and Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015) (Health Care Antiseptics Proposed Rule) and “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) (Consumer Antiseptic Rubs Proposed Rule).

Over the course of these rulemakings, benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol were classified as Category III for use as active ingredients in consumer antiseptic rub products and health care personnel hand 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 or as a health care personnel hand rub.

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, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution does not conform to the 1994 TFM, as further amended by the 2015 Health Care Antiseptics Proposed Rule, the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule, and do not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

According to the product label, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution purportedly contains the active ingredient ethanol 75% v/v. However, as previously discussed, FDA laboratory analyses of a batch of this product detained at the border demonstrate that Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution contains no traceable amount of ethanol.4 Such a product does not conform to the TFM or the other applicable requirements, nor is it consistent with the formulations described in the guidances setting forth FDA’s temporary policies for hand sanitizers and health care personnel hand rubs during the COVID-19 public health emergency.5

Additionally, this topical antiseptic, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, is misbranded under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee).

The drug product 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, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution is labeled to contain ethanol 75% v/v. However, FDA laboratory analyses of a batch of this product demonstrate that the product contains no traceable amount of ethanol, far less than that stated in its product labels. Thus, the misleading representations of the concentration of the active ingredient ethanol on the Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution labeling cause the product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

This product is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution is a nonprescription drug governed by 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 it 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).

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 product. 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 drugs and drug products manufactured by your firm on Import Alert 66-78 on October 2, 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 practices 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 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 you 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 3009028673 and ATTN: Christina Capacci-Daniel.

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

CC:
Registered U.S. Agent:
Aldo Martinez
Fiesta Union LLC
34 Pinar del Rio Ave.
Brownsville, TX 78526

__________________________

1 https://www.cdc.gov/handwashing/hand-sanitizer-use.html

2 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. In addition to the violative sample results detailed above that demonstrate the subpotency of the topical antiseptic product declared and labeled as manufactured at your facility, a review of the purported formulations on the drug product labeling further indicates that this product is not prepared consistent with FDA’s temporary policy set forth in the guidance. Therefore, this product does not fall within the Agency’s temporary policy not to take action against firms manufacturing hand sanitizer products for violations of section 501(a)(2)(B) of the FD&C Act.

3 We note that your Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution labeling contains conflicting information regarding whether it should be used as a consumer antiseptic rub or a health care personnel hand rub. The term “hand sanitizer” generally refers to consumer antiseptic rubs, and your product labeling both indicates that the product is a “hand sanitizer” and suggests that it should be used as a health care personnel hand rub (i.e., “Use(s) Health care personnel hand rub to help reduce bacteria that potentially can cause disease”). The Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution product, however, does not conform to the requirements for either a consumer antiseptic rub or a health care personnel hand rub, as further described below.

4 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 at 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.

5 See, e.g., Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Because Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution is not consistent with the formulations in these guidances, it does not fall within any temporary Agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act.

 
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