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  5. DeVere Manufacturing Inc. - 715846 - 11/12/2025
  1. Warning Letters

WARNING LETTER

DeVere Manufacturing Inc. MARCS-CMS 715846 —

Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
320-26-16
Product:
Drugs
Recipient:
Recipient Name
Mr. Randy D. Stevenson
Recipient Title
President
DeVere Manufacturing Inc.

1923 Beloit Avenue
Janesville, WI 53546
United States

rstevenson@deverechemical.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-26-16

November 12, 2025

Dear Mr. Stevenson:

The United States Food and Drug Administration (FDA) inspected your drug product manufacturing facility, DeVere Manufacturing Inc., FEI 3012088459, at 1923 Beloit Ave., Janesville, WI, from June 2 to 4, 2025.

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 do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your June 20, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

You manufacture over-the-counter (OTC) drug products, (b)(4) Hand Sanitizer Foam, both alcohol and alcohol-free formulas, using the same equipment that you use to manufacture non-drug products, including industrial cleaning detergents and disinfectants such as Bowl Cleaner, a strongly acidic (pH <2) toilet cleaner, and (b)(4).

In your response, you commit to maintaining cleaning records for all shared equipment and performing additional cleaning validation. However, your response is inadequate. Under CGMP, it is unacceptable to manufacture drug products using the same equipment you use to manufacture non-pharmaceutical products due to the risk of cross-contamination. Inadequate removal of active ingredients and product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.

Further, we acknowledge your commitment in your August 4, 2025, response to cease production of all benzalkonium chloride-containing drug products at this facility for the U.S. market. We acknowledge your intent to delist your (b)(4) product line by September 30, 2025.

In response to this letter, provide:

  • Confirmation of whether you will discontinue manufacturing drug products on shared equipment in your facility and implement appropriate controls to prevent cross-contamination.
  • If you intend to continue to manufacture both pharmaceutical and non-pharmaceutical products at your facility, provide a plan to show how you will maintain appropriate separation with dedicated manufacturing equipment for your pharmaceutical manufacturing and industrial product manufacturing operations.
  • Provide a risk assessment for all drugs you have previously produced on equipment shared with industrial products. For each product, assess the risk of potential contamination due to the shared equipment, and provide your plans for addressing the product quality and patient safety risks for any product still in distribution, including potential recalls or market withdrawals.
  • Appropriate improvements to your cleaning procedures with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:
    o Drugs with higher toxicities
    o Drugs with higher drug potencies
    o Drugs of lower solubility in their cleaning solvents
    o Drugs with characteristics that make them difficult to clean
    o Swabbing locations for areas that are most difficult to clean
    o Maximum hold times before cleaning

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, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)).

You failed to conduct adequate finished product release testing for each batch of your hand sanitizer drug products, including but not limited to, testing of the identity and strength of each active ingredient, testing for impurities, and testing for objectionable microorganisms. You provided records demonstrating that you test your hand sanitizer drug products for (b)(4). Your records also demonstrate titration, for determination of quaternary ammonium cations in the benzalkonium chloride hand sanitizers. However, in the past two years, you manufactured more than (b)(4) batches of hand sanitizer using (b)(4) water, which is unsuitable for use as a component of a drug product. You did not perform microbiological testing on those batches made with unsuitable water.

Your response is inadequate. You did not provide sufficient details of the test methods and specifications you intend to implement for your OTC drug products to ensure your finished products meet appropriate standards prior to release and distribution.

Full release testing, including strength and identity testing of the active ingredient and appropriate microbiological testing, must be performed before drug product release and distribution. Without adequate testing, there is no 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 specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.
    o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
    o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

3. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., benzalkonium chloride, ethanol, glycerin) used in the manufacture of your OTC drug products. In addition, you relied on your suppliers’ certificate of analysis without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.

Identity testing for high-risk drug components ethanol and glycerin include a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for methanol or diethylene glycol (DEG) or ethylene glycol (EG) levels, respectively. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.

Ethanol

You failed to adequately test each shipment of each lot of ethanol, used as an active pharmaceutical ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-testing-alcohol-ethanol-and-isopropyl-alcohol-methanol.

Glycerin

You failed to adequately test each shipment of each lot of glycerin, used as an inactive ingredient, for DEG or EG contamination.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-glycerin-propylene-glycol-maltitol-solution-hydrogenated-starch-hydrolysate-sorbitol.

In your response, you commit to full USP compendial testing of raw materials from your vendors, including methanol testing for ethanol and DEG/EG for glycerin. Your response is inadequate. You failed to specify the timing for implementation of testing and how you intend to sample and monitor incoming materials. Further, you did not evaluate previously distributed drug products or describe how suppliers will be qualified.

Without adequate testing, you do not have appropriate assurance that components conform to appropriate specifications prior to use in the drug products you manufacture. As a manufacturer, you have the responsibility to sample, test, and examine drug components before use in production to assure adequate quality.

In response to this letter, provide:

  • 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 Certificates of Analysis (COA) 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. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B and C of the United States Pharmacopeia (USP) monograph.
  • A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
  • The chemical and microbiological quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
  • 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.
  • A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
  • A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.

4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your quality unit (QU) failed to exercise its responsibility to adequately review production records prior to approval (e.g., failed to investigate out-of-specification test results, reprocessing, and errant label reconciliation) and failed to establish and follow written procedures (e.g., annual product reviews, complaints, recalls, CGMP training, process validations, analytical method validation).

Additionally, your QU failed exercise its responsibility to ensure that your component water is suitable for its intended use. Our inspection documented that you used “(b)(4) water” (also referred to as “(b)(4) water” in your batch records) as the main component of manufacturing OTC hand sanitizers. Although your OTC product labels identify purified water as the first inactive ingredient, your QU does not ensure that purified water is used in the product formulation.

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations. For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision.

In response to this letter, provide:

  • A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
    o A determination of whether procedures used by your firm are robust and appropriate
    o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
    o A complete and final review of each batch and its related information before the QU disposition decision
    o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
  • A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the new system consistently produces water adhering to Purified Water, USP monograph specifications and appropriate microbial limits.
  • A detailed risk assessment addressing the potential effects of the use of (b)(4) water on the quality of all drug product lots currently in U.S. distribution and within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.

Repeat Violations at Facility

In a previous inspection dated January 26 to February 2, 2018, FDA cited similar CGMP violations for the failure of the quality unit to adequately exercise its responsibilities. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

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 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.

Conclusion

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 FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug product manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-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.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012088459 and ATTN: Kara S. Quinn.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

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