# FDA 483 - Dallas-Fort Worth Fertility Associates, P.A. - December 09, 2019

Source: https://www.globalkeysolutions.net/records/483/dallas-fort-worth-fertility-associates-pa/a068f88a-cd8f-4133-bfc0-d63b9c274a34

> FDA 483 for Dallas-Fort Worth Fertility Associates, P.A. on December 09, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dallas-Fort Worth Fertility Associates, P.A.
- Inspection Date: 2019-12-09
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Dallas-Fort Worth Fertility Associates, P.A. in Dallas was inspected by the FDA, revealing a critical issue in their donor eligibility process. The firm was cited for determining an HCT/P donor eligible before receiving all required relevant communicable disease agent testing results. This practice indicates a failure to ensure donor safety and compliance with regulatory standards.

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.globalkeysolutions.net/companies/dallas-fort-worth-fertility-associates-pa/5d619c02-0c14-462c-887c-5f0a69e6e1b4

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