WARNING LETTER
Mohawk Laboratories Division of NCH Corporation MARCS-CMS 635780 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Drugs
- Recipient:
-
Recipient NameMr. Andrew Schreyer
-
Recipient TitleSenior Vice President
- Mohawk Laboratories Division of NCH Corporation
2730 Carl Road
Irving, TX 75062
United States
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
United States
DATE: 1/18/2023
Case #: 635780
WARNING LETTER
Dear Mr. Schreyer:
Your facility was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers) until June 10, 2022 and you distributed hand sanitizer drug products as recently as April 19, 2022. These drug products were manufactured at your facility, Mohawk Laboratories, Division of NCH Corporation, FEI 1610021, located at 2730 Carl Road, Irving, TX. FDA conducted testing of three lots of your consumer hand sanitizer drug products1. Your firm also provided impurity test results for additional lots of consumer hand sanitizer, labeled as Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer.
The results of the FDA laboratory testing of lots of your drug products and the results of testing of additional lots provided by your firm demonstrate that these drug products manufactured at your facility are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(a)(2)(B)),2 in that contamination with the impurities acetaldehyde and acetal at unacceptable levels demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
Additionally, FDA has reviewed your September 6,2022 response to our information request letter dated July 28, 2022, which notified you of the adverse findings and requested clarification of your manufacturing operations, and acknowledge receipt of your subsequent correspondence. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).
Adulteration Violations
You manufactured Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer at your facility. FDA collected three lots of your drug products and FDA laboratory testing of your products found that all three lots of the drug products contained acetaldehyde and acetal impurities at unacceptable levels. See table below.
|
Product Name |
Lot Number |
Test Results (ppm) |
|
|
Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution, 2 X 2.5 GL, No Exp. Date |
12014115 |
Acetaldehyde |
(b)(4) |
|
Acetal |
(b)(4) |
||
|
Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution, 2 X 2.5 GL, No Exp. Date |
12014804 |
Acetaldehyde |
(b)(4) |
|
Acetal |
(b)(4) |
||
|
Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution, 2 X 2.5 GL, No Exp. Date
|
12015401 |
Acetaldehyde |
(b)(4) |
|
Acetal |
(b)(4) |
||
Acetaldehyde and acetal are known impurities of alcohol, as delineated in the United States Pharmacopeia (USP). The USP monograph for alcohol limits acetaldehyde and acetal to not more than (NMT) 10mL/L, 10 ppm (expressed as acetaldehyde). Alcohol not meeting the specification for acetaldehyde and acetal is deemed adulterated under section 501(b) of the FD&C Act. Alcohol represents a significant component of your drug product; therefore, you must have a specification for acetaldehyde and acetal per 21 CFR 211.160(b). Further, finished product testing of each batch of drug product is required under 21 CFR 211.165. The test results for acetaldehyde and acetal impurities in your drug products are unacceptable because these results are higher than the levels expected if the alcohol contained in your products complied with compendial standards and if you had conducted finished product testing with a specification for acetaldehyde and acetal. Therefore, your drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act.
Acetaldehyde appears to be genotoxic, and potentially carcinogenic, when in direct contact with tissues.
On July 28, 2022, FDA sent you an information request letter informing you of the unacceptable levels of impurities in your Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer and requested additional information including impurity testing of reserve samples to determine the quality of all lots of your hand sanitizer drug products within expiry.3
In your response dated September 6, 2022, you indicated you distributed hand sanitizer drug products as recently as April 19, 2022.
On November 29, 2022, FDA held a teleconference with you. We recommended you consider removing the three lots of your Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer that FDA tested from the U.S. market. On November 30, 2022, your firm provided impurity test results from reserve samples of your Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer drug product. The test results for the drug products manufactured at your facility demonstrated that the drug products contained acetaldehyde and acetal impurities at unacceptable levels.
On December 9, 2022, you issued a voluntary nationwide recall of Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer due to the presence of acetaldehyde and acetal impurities.
On December 14, 2022, FDA notified the public of the unacceptable impurity results in your hand sanitizer drugs products at the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
The contamination with acetaldehyde and acetal in drug products manufactured in your facility demonstrate 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.
CGMP Consultant Recommended
Based upon the nature of the violations we identified, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate 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.
Drug Production Ceased
We acknowledge your commitment to cease production of drugs at this facility and your response stated you do not intend to resume manufacturing any drugs at this facility in the future.
If you plan to resume manufacturing drugs, notify this office before resuming your operations.
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.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to address any violations.
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 complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Your written notification should refer to case # 635780.
Please electronically submit your reply, on company letterhead, to Kenitra D. Hewitt, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov. In addition, please submit a signed copy of your response to kenitra.hewitt@fda.hhs.gov and Ronda.Loyd-Jones@fda.hhs.gov.
If you have questions regarding the contents of this letter, you may contact Kenitra Hewitt via phone at 817-334-5218 Ext. 1104 or email at kenitra.hewitt@fda.hhs.gov.
Sincerely,
/S/
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations, Division II
Cc:
Mr. Michael J. Near-General Counsel-Regulatory Affairs
NCH Corporation
mnear@nch.com
___________________________
1 Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution, 2 X 2.5 GL, Lot 12014115, Batch 01253477; Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution, 2 X 2.5 GL, Lot 12014804, Batch 01254407; Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution, 2 X 2.5 GL, Lot 12015401, Batch 01255712.
2 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, the 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. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). This guidance communicated the agency’s temporary policy that we did not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepared 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 were present. These circumstances included preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. Because Mohawk Laboratories hand sanitizer drug products were not consistent with the formulations described in these guidances, they did not fall within any temporary agency 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 In the July 28, 2022 letter, FDA had described “unacceptable” levels of acetal and acetaldehyde as being above 50 ppm. That number had originally been described in the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) and had represented FDA’s intent to not take action against products within that level of impurity, provided that the other circumstances described in the guidance were present. As noted in Footnote 2 above, that temporary policy has been withdrawn. Acetal and acetaldehyde levels in alcohol must not exceed the 10 ppm limit prescribed by the USP.