JW Nutritional LLC — FDA Warning Letter, April 15, 2026: CGMP/OTC Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at JW Nutritional LLC

WARNING LETTER JW Nutritional LLC MARCS-CMS 722096 — April 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-67 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Jesse Windrix Recipient Title President JW Nutritional LLC 4700 S. Hardin Blvd., Suite 260 McKinney , TX 75070-2411 United States jesse@jwnutritional.com 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) contaminatio