# FDA 483 - Repromed Fertility Center - April 01, 2026

Source: https://www.keypedia.com/records/483/repromed-fertility-center/7f84b8bc-af1c-4089-83b9-7fafcda89aae

> FDA 483 for Repromed Fertility Center on April 01, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Repromed Fertility Center
- Inspection Date: 2026-04-01
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Repromed Fertility Center in Dallas, TX, conducted from March 31 to April 1, 2026, revealed two significant observations. The firm failed to properly determine HCT/P donor eligibility based on complete screening and testing results. Additionally, the facility did not adequately remove donor personal identifying information from records submitted to a third-party facility.

## Related Documents

- [WARNING_LETTER - 2014-04-02](https://www.keypedia.com/records/warning_letter/repromed-fertility-center/219f7b6b-b537-4d82-a6b6-466e34601600)
- [483 - 2019-11-22](https://www.keypedia.com/records/483/repromed-fertility-center/adb505fe-2893-4435-a46e-2c2dee4e5c5b)

## Related Officers

- [Michelle Paxon](https://www.keypedia.com/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)
- [Abby L. Mozeke](https://www.keypedia.com/people/abby-l-mozeke/ce4ecbbc-0108-483e-aff3-d5320e50114f)

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