# FDA 483 - Fertility Specialists of Texas PLLC. - March 18, 2019

Source: https://www.globalkeysolutions.net/records/483/fertility-specialists-of-texas-pllc/8e3aa0e6-d9b0-42bf-b885-51fa6a2276f3

> FDA 483 for Fertility Specialists of Texas PLLC. on March 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fertility Specialists of Texas PLLC.
- Inspection Date: 2019-03-18
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Fertility Specialists of Texas PLLC in Frisco, TX, was inspected and cited for significant deficiencies in their donor screening processes for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included inadequate screening for communicable disease agents like ZIKA virus due to incomplete donor history questionnaires. Additionally, the firm lacked comprehensive written procedures for physical examinations and determining donor eligibility.

## Related Documents

- [483 - 2024-03-29](https://www.globalkeysolutions.net/records/483/fertility-specialists-of-texas-pllc/ee1a4b2b-c691-43f2-adce-3606c7b7cc2f)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/fertility-specialists-of-texas-pllc/a38a7d91-420d-41bb-875f-956bdfc5f16b

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