# FDA 483 - FluoroMed Products, L.P. - March 14, 2025

Source: https://www.keypedia.com/records/483/fluoromed-products-lp/decb1953-7c34-47eb-93c1-debb8e079ca5

> FDA 483 for FluoroMed Products, L.P. on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FluoroMed Products, L.P.
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of FluoroMed Products, L.P. in Round Rock, TX, an API manufacturer, revealed significant cGMP deficiencies. The firm failed to adequately evaluate and establish formal agreements with contract laboratories used for API testing. Additionally, the inspection found a lack of proper procedures for manual integration of gas chromatographs, impacting the quality and purity of manufactured APIs.

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)

Company: https://www.keypedia.com/companies/fluoromed-products-lp/90335b00-e469-483f-9254-5f43d663c574

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