Complete Nutrition
FDA issued a warning letter to JW Nutritional LLC (McKinney, TX) following a September 2025 inspection of their OTC drug manufacturing facility. The agency cited significant CGMP violations including failure to perform adequate identity and contamination testing on incoming components, lack of process validation, inadequate water system validation, and use of food/dietary supplement microbiological standards instead of USP drug standards. FDA warned that failure to correct these violations could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.
Required actions (4)
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.
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.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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