# FDA 483 - Family Fertility Center - June 26, 2019

Source: https://www.keypedia.com/records/483/family-fertility-center/1724437c-2ce6-413a-91f7-521934680f8d

> FDA 483 for Family Fertility Center on June 26, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Family Fertility Center
- Inspection Date: 2019-06-26
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: The FDA inspected Family Fertility Center in Houston, TX, and found significant issues with their donor screening and eligibility determination processes for reproductive tissues. The firm failed to adequately screen oocyte donors for communicable disease risks, including Zika virus, and did not properly document donor eligibility or retain required records. These deficiencies led to the use of tissues from donors who were not fully assessed or deemed eligible according to regulations.

## Related Documents

- [WARNING_LETTER - 2019-06-26](https://www.keypedia.com/records/warning_letter/family-fertility-center/fe84dd1c-513c-4524-8e98-213e21078dee)
- [483 - 2020-03-16](https://www.keypedia.com/records/483/family-fertility-center/27a2a52b-986c-49f7-88e6-fe58c929a929)
- [483 - 2024-01-30](https://www.keypedia.com/records/483/family-fertility-center/4ceb5727-1686-4ee5-aa8f-498b57d8b9b6)

## Related Officers

- [Elmina E Akwo](https://www.keypedia.com/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.keypedia.com/companies/family-fertility-center/b744bbbf-0b40-4500-9bbb-77ee1c9b29f9

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