# FDA 483 - Repromed Fertility Center - November 22, 2019

Source: https://www.keypedia.com/records/483/repromed-fertility-center/adb505fe-2893-4435-a46e-2c2dee4e5c5b

> FDA 483 for Repromed Fertility Center on November 22, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Repromed Fertility Center
- Inspection Date: 2019-11-22
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Repromed Fertility Center in Dallas, TX, from November 4-22, 2019, identified significant deficiencies in their screening and testing procedures for egg donors. The firm failed to adequately screen donors for communicable disease risk factors, specifically regarding Zika virus, and did not test two directed egg donors for West Nile Virus. These issues indicate a failure to ensure donor eligibility and product safety.

## Related Documents

- [WARNING_LETTER - 2014-04-02](https://www.keypedia.com/records/warning_letter/repromed-fertility-center/219f7b6b-b537-4d82-a6b6-466e34601600)

## Related Officers

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

Company: https://www.keypedia.com/companies/repromed-fertility-center/c923c944-b19e-4e12-ac3c-5df17c9652b5

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