# FDA 483 - United Laboratories Manufacturing, LLC - August 15, 2025

Source: https://www.keypedia.com/records/483/united-laboratories-manufacturing-llc/e65c5bad-f297-45f1-b69a-f8f83704cf8e

> FDA 483 for United Laboratories Manufacturing, LLC on August 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Laboratories Manufacturing, LLC
- Inspection Date: 2025-08-15
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: United Laboratories Manufacturing, LLC was inspected and found to have severe deficiencies across its quality systems. Key issues include a fundamental breakdown in the Quality Unit's oversight, distribution of out-of-specification drug products, inadequate deviation and OOS investigations, and insufficient employee training. These failures compromise product quality, regulatory compliance, and potentially consumer health.

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## Related Officers

- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)
- [Mercedes N. Overton](https://www.keypedia.com/people/mercedes-n-overton/d3c24898-20d4-45f8-adda-24431066c9e6)

Company: https://www.keypedia.com/companies/united-laboratories-manufacturing-llc/973d4b48-b42b-4418-b827-ed52d8881802

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