# FDA 483 - Southwest Fertility Center - March 16, 2021

Source: https://www.keypedia.com/records/483/southwest-fertility-center/2716aed2-5114-4aaa-b5d8-46aee7a24f11

> FDA 483 for Southwest Fertility Center on March 16, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Southwest Fertility Center
- Inspection Date: 2021-03-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Southwest Fertility Center in Phoenix, AZ, identified a critical failure in donor screening protocols. The firm did not test donors of multiple oocyte and semen donations for West Nile Virus, a relevant communicable disease agent, before deeming them eligible. This lapse raises concerns regarding the safety and compliance of their reproductive tissue operations.

## Related Officers

- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

Company: https://www.keypedia.com/companies/southwest-fertility-center/88230ca1-5d96-4b57-8c8c-84495eb723f6

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6