What happened
Original notice title
JW Nutritional LLC MARCS-CMS 722096, April 15, 2026
From the archived source record
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 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). During our inspection, our investigator observed specific violations including, but not limited to, the following. 1. 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. 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. 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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- c0f0695d76e8
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →