# FDA 483 - JW Nutritional, LLC - September 26, 2025

Source: https://www.globalkeysolutions.net/records/483/jw-nutritional-llc/f243de2b-26fb-49c3-856c-fdf835c2f6de

> FDA 483 for JW Nutritional, LLC on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JW Nutritional, LLC
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of JW Nutritional LLC, a contract manufacturer of OTC drug products in McKinney, TX, revealed significant deficiencies in their manufacturing processes. The firm failed to establish adequate process validation for drug products, ensure complete component testing for raw materials, and properly qualify equipment, specifically their water system. These issues indicate a lack of control over critical manufacturing operations and product quality.

## Related Officers

- [Milton J. De Jesus Tavarez](https://www.globalkeysolutions.net/people/milton-j-de-jesus-tavarez/24d4ed81-7c7e-42d2-8888-1c56c25eec67)

Company: https://www.globalkeysolutions.net/companies/jw-nutritional-llc/52b2e3d6-387b-4036-ab6a-fe7cac6e0812

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9