JW Nutritional LLC(320-26-67)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-26-67

April 15, 2026

Dear Mr. Windrix:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, JW Nutritional LLC, FEI 3031468435, at 4700 S. Hardin Blvd., Suite 260, McKinney, TX, from September 22 to 26, 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 October 17, 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 test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).

Your firm failed to ensure that components used in the manufacture of your over-the-counter (OTC) (b)(4) drug product “(b)(4)” are suitable for their intended use. You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4)).

Products Contain Ingredients at Risk for (b)(4) Contamination

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4).

Identity testing for (b)(4), and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for (b)(4) levels. 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.

In your response, you state that you will perform additional testing for (b)(4).

Your response is inadequate in that you did not provide a detailed plan for how your components will be assessed against compendial requirements. Also, you did not test all previous incoming components for presence of (b)(4).

Without adequate testing, you do not have scientific evidence that the components conform to the appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before you use them in production to ensure that acceptable quality parameters are met.

In response to this letter, provide:

• A commitment to provide (b)(4) 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 (b)(4).

• A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including but not limited to (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (CAPA) to secure supply chains in the future, including but not limited to ensuring that all incoming raw material lots are from fully qualified manufacturers and are free from unsafe impurities. Detail these actions in your response to this letter.

• 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 suppliers’ 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 suppliers’ results through initial validation, as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4), and certain additional high-risk components, we note that this includes the performance of (b)(4) of the USP monograph.

2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Lack of Process Validation

You failed to validate your production and process controls.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluates batches to determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

See FDA’s guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.

In your response, you state that you will perform process validation on the next purchase order batches by April 15, 2026.

Your response is inadequate because you did not provide your interim plan for drugs distributed before process validation activities are complete to ensure you produced drug products of acceptable quality.

Inadequate (b)(4) System Validation

Your firm failed to adequately qualify your (b)(4) system to ensure it produces (b)(4) that meets appropriate chemical and microbial attributes. You use (b)(4) as a component in your OTC drug product and to clean the manufacturing equipment.

In addition, you do not adequately demonstrate that your (b)(4), at a minimum, meets (b)(4) USP monograph and appropriate chemical and microbiological limits. Specifically, you failed to perform (b)(4) testing as required. Furthermore, there is no indication that you monitor your (b)(4) for objectionable microorganisms (e.g., (b)(4)).

(b)(4) must be suitable for its intended use. Each lot must be tested to ensure conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts, as well as characterization and identification of contamination, is integral to ensuring (b)(4) is of acceptable quality for use in manufacturing operations.

In your response, you state that you have updated your procedures and plan to complete (b)(4) system validation within six weeks. You also state you will perform additional testing for (b)(4).

Your response is inadequate because you did not provide adequate details regarding your plan for performing (b)(4) system validation, nor did you provide an interim plan to ensure that the (b)(4) is suitable for its intended use. Additionally, you did not provide a detailed plan for how you will access your plan against compendial requirements. The analytical test report you plan to use for (b)(4) inappropriately uses MPN/g (most probable number per gram) as the limit for total coliforms test. This methodology does not align with USP requirements or standard industry practice for (b)(4) testing.

In response to this letter, provide:

• A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.

• A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.

• Process performance protocol(s), and written procedures for qualification of equipment and facilities.

• A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.

• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures your (b)(4) system consistently produces (b)(4) that meets (b)(4) USP monograph specifications and appropriate microbial limits.

3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Your firm has inadequate microbiological release specifications for your OTC drug products. Specifically, your firm applied microbiological reference standards intended for foods and nutritional and dietary supplements to your (b)(4)-ounce tube. The applicable test standards for your product are USP ⟨61⟩ Microbial Enumeration Tests, USP ⟨62⟩ Tests for Specified Microorganisms.

Your current specification establishes a Total Plate Count limit of not more than (NMT) (b)(4) cfu/g and a Yeast & Mold limit of NMT (b)(4) cfu/g, which are (b)(4)-fold higher than generally accepted levels for (b)(4) drug products (Total Aerobic Microbial Count NMT (b)(4) cfu/g and Total Combined Yeasts/Molds Count NMT (b)(4) cfu/g). Additionally, your specification fails to include testing for (b)(4).

In response to this letter, provide:

• A list of microbial specifications, including test methods, used to analyze each batch of your drug product before a batch disposition decision.

• An action plan and timelines for conducting 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.

• A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug product, take rapid corrective actions, such as notifying customers and product recalls.

• Clarification on whether you intend to continue production of your OTC drug product.

Responsibilities as a Contractor

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document at https://www.fda.gov/media/86193/download.

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 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 3031468435 and ATTN: Chhaya Shetty.

Sincerely,
/S/

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