WARNING LETTER
Distribuidora Lagunera del Norte S.A. de C.V.
MARCS-CMS 610939 —
March 23, 2021
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. Gerardo Pacheco
Distribuidora Lagunera del Norte S.A. de C.V.
Av Juarez #5735-5
27085
Torreón
,
Coah.
Mexico
Issuing Office:
Center for Drug Evaluation and Research
United States
Warning Letter 320-21-37
March 23, 2021
Dear Mr. Pacheco:
Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a topical antiseptic drug product, labeled as weper Clean Solutions Hand Sanitizer. A representative from your company has stated that this drug product was manufactured at your facility, Distribuidora Lagunera del Norte S.A. de C.V., FEI: 3017394466, at Av. Juarez #5735-5, Torreón Coahuila, Mexico. Following an attempt to import weper Clean Solutions 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, which is 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) of the FD&C Act (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, weper Clean Solutions Hand Sanitizer drug product 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 (a), (c) and (ee) of the FD&C Act, 21 U.S.C. 352(a), (c) and (ee). Introduction or delivery for introduction of such a product 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
Weper Clean Solutions Hand Sanitizer, which is manufactured at your facility, is labeled to contain 70% of 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 an average of only 28% v/v ethanol. This topical antiseptic drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the product lower than that which is declared on its labeling.
CDC recommends
1
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 “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 in “clinics” and “doctor’s offices.”
While the contaminated drug product detailed above was shipped to the United States, information available to FDA demonstrated that all of your topical antiseptic drug product was 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 January 28, 2021, 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 topical antiseptic drug product described above, which was labeled as containing 70% ethanol, in fact contained an average of 28% 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 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.
The subpotency of this topical antiseptic drug product 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
Weper Clean Solutions 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), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a topical antiseptic.
Examples of claims observed on the weper Clean Solutions Hand Sanitizer 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:
“Antiseptic hand gel that does not require rinsing…”
“APPLICATIONS: It is used with hand disinfection in clinics, doctor’s offices, offices, schools, dining rooms, food plants, and fast-acting and drying establishments…”
“DIRECTIONS FOR USE: With dry hands take a portion of GEL, rub the entire surface of the hands, interdigital spaces and wrists for 15-30 seconds until alcohol dries.”
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 weper Clean Solutions 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 “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, weper Clean Solutions Hand Sanitizer 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 does 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, weper Clean Solutions Hand Sanitizer purportedly contains the active ingredient ethyl alcohol 70%. However, as previously discussed, FDA laboratory analyses of a batch of this product detained at the border demonstrated that weper Clean Solutions Hand Sanitizer contains ethanol in a concentration that is less than the 70% stated on its product label and less than the amount of ethanol described in the 1994 TFM.
4
Such a product does not conform with the TFM or the applicable requirements, nor is it consistent with the formulations described in the guidances setting forth FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency.
5
Additionally, this topical antiseptic, is misbranded under under sections 502(a), (c), and (ee) of the FD&C Act, 21 U.S.C. 352(a), (c), and (ee).
This topical antiseptic 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, weper Clean Solutions Hand Sanitizer is labeled to contain ethanol 70%. However, FDA laboratory analyses of a batch of this product demonstrate that the product contains concentrations of ethanol that are far less than that stated on its respective product labels. Thus, the misleading representations of the concentration of the active ingredient ethanol on the weper Clean Solutions Hand Sanitizer labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
Weper Clean Solutions Hand Sanitizer is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on the product label above the National Drug Code (NDC) number, which creates the impression that the drug is approved or legally marketable (see 21 CFR 207.77(b)). As previously noted, your Weper Clean Solutions Hand Sanitizer is not the subject of an FDA-approved application. Therefore, a labeling representation suggesting that your product is FDA-approved is false or misleading.
Further, weper Clean Solutions Hand Sanitizer is not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66. Specifically, the product label fails to include a Drug Facts panel. Therefore, this product is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because weper Clean Solutions 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).
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 manufactured by your firm on Import Alert 66-78 on March 10, 2021, 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 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 3017394466 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
SAGO Investments
1606 Eagle Trace Dr.
Laredo, TX 78045
(b)(4), (b)(6)
___________________________
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 a 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 testing results detailed above that demonstrate the subpotency of hand sanitizer products manufactured at your facility, a review of the purported formulations on the drug products’ 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 weper Clean Solutions Hand Sanitizer 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. 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., “It is used with hand disinfection in clinics, doctor’s offices. . .”). The weper Clean Solutions Hand Sanitizer 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 weper Clean Solutions Hand Sanitizer is not consistent with the formulations described 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.
Content current as of:
03/30/2021
Regulated Product(s)
Drugs