# FDA 483 - Dallas Forth-Worth Fertility Associates - February 22, 2019

Source: https://www.keypedia.com/records/483/dallas-forth-worth-fertility-associates/04015529-4267-4863-95a4-a6119eea8bd3

> FDA 483 for Dallas Forth-Worth Fertility Associates on February 22, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dallas Forth-Worth Fertility Associates
- Inspection Date: 2019-02-22
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of James W. Douglas, M.D. dba IVF Plano in Plano, TX, a reproductive HCT/P establishment, revealed two significant observations. The firm failed to adequately screen donors for communicable disease agents, specifically regarding Zika risk factors, and lacked established, defined, and documented procedures for determining donor eligibility.

## Related Officers

- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/dallas-forth-worth-fertility-associates/24ed64e9-7d71-4b5e-b2f9-811a56a57946

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