- Delivery Method:
- VIA UPS
Recipient NameMr. Jim McConnell
- McConnell Labs Inc.
406 SW Umatilla Ave.
Redmond, OR 97756
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
October 18, 2022
Dear Mr. McConnell:
Your facility is registered with the U. S. Food and Drug Administration as a manufacturer of over-the-counter (OTC) drug products, including consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers). The FDA has reviewed the records you submitted in response to our July 30, 2021, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 374(a)(4)) for your facility, McConnell Labs Inc., FEI 3010298400, at 406 SW Umatilla Ave., Redmond, OR.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR) parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs as described in your response to our 704(a)(4) request do not conform to CGMP regulations, your drug products are deemed adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).
1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).
Your firm manufactured OTC drug products, including Light Elegance Hand Sanitizer.1. Your response to our request for records and other information under section 704(a)(4) indicated that you did not adequately test each lot of incoming raw materials (e.g., active ingredients, ethanol, and isopropyl alcohol) used to manufacture your drug products to determine their identity.
For example, in response to our request, you were unable to provide evidence that you performed any testing on your incoming raw materials. Instead, you only provided your suppliers’ Certificates of Analysis (COA). Additionally, your ethanol supplier’s COA states that the product “is not intended for use as an active ingredient in drug manufacturing nor as a medical device or disinfectant.”
In addition, in your response, you state that you do not test for methanol on any incoming lots of ethanol and isopropyl alcohol. The use of ethanol or isopropyl alcohol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See the FDA’s guidance document, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19), at https://www.fda.gov/media/145262/download.
Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality, including testing for the presence of methanol in ethanol and isopropyl.
In response to this letter, provide:
- A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.2
- The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
- A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
- A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.
2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Based on the records and information you provided, you did not conduct adequate finished drug product testing on all drug products.
Specifically, in response to our request to provide release test specifications, analytical procedures for the analysis of drug products and testing data, you submitted, in part, a procedure stating you evaluate the alcohol concentration of your hand sanitizers. However, you also provided your COA reports and batch records which demonstrated that your hand sanitizer drug products are only tested for weight, density, color, viscosity, and smell.
Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.
In response to this letter, provide:
- A list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making a lot disposition decision, and the associated written procedures.
- An action plan and timelines for conducting full chemical and microbiological testing of retained samples to determine the quality of all batches of drug product distributed in the United States that are within expiry as of the date of this letter.
- A summary of all results including methanol, benzene, acetal, and acetaldehyde for all hand sanitizer batches released and distributed. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Based on the records and information you provided, you did not demonstrate that you established and followed appropriate storage conditions and expiration dates of the drug products manufactured at your facility.
Specifically, you reported that the expiry period assigned and applied to your hand sanitizer products is “36 months period [sic] after opening.” You also provided COA reports which state that these products have an expiration “10 years past the manufacturing date.”
You have not provided data to support the multiple expiry periods of your hand sanitizers. Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.
In response to this letter, provide:
- A comprehensive, independent assessment, and corrective and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
o Stability-indicating methods
o Stability studies for each drug product in its marketed container-closure system before distribution is permitted
o An ongoing program in which representative batches of each drug product are added each year to the program to determine if the shelf-life claim remains valid
o Detailed definition of the specific attributes to be tested at each station(timepoint)
- All procedures that describe these and other elements of your remediated stability program.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should perform a comprehensive audit of your entire operation for CGMP compliance and also evaluate the completion and efficacy of any identified corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with the FDA.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. 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 the FDA to withhold issuance of Export Certificates. The 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 your facility 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.
Please identify your responses with the unique identifier: CMS 638958. Send your electronic response to ORAPHARM4_Responses@FDA.HHS.GOV with ATTN:CDR Steven E. Porter, Jr., or mail your written response to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506
If you have questions regarding the contents of this letter, please contact LCDR Rumany Penn, compliance cfficer, at email@example.com or (949) 608-4409.
CDR Steven E. Porter, Jr. Director,
Division of Pharmaceutical Quality Operations IV
1 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. 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. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). Because McConnell Labs Inc.’s hand sanitizer products were not prepared under the circumstances described in this guidance, they do 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.
2 Per section 501 of the FD&C Act, “current good manufacturing practice” for the purposes of complying with the requirement in section 501(a)(2)(B) includes “managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”