# FDA 483 - Washington Fertility Center - November 17, 2021

Source: https://www.keypedia.com/records/483/washington-fertility-center/4e8438b2-9683-497f-81d1-47ccfe160153

> FDA 483 for Washington Fertility Center on November 17, 2021. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Washington Fertility Center
- Inspection Date: 2021-11-17
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: The Washington Fertility Center in Annandale, VA, was cited for failing to adequately screen anonymous oocyte donors for communicable disease risks. The firm's Donor History Questionnaire lacked critical screening questions for various neurological conditions, blood transfusions, and animal exposure, and also used an outdated screening question for Zika virus risk. This is a repeat observation, indicating a persistent issue with donor screening practices.

## Related Documents

- [483 - 2023-11-02](https://www.keypedia.com/records/483/washington-fertility-center/f6f8e43e-a3cf-436e-84e2-1e61f7c4da0b)
- [WARNING_LETTER - 2023-11-02](https://www.keypedia.com/records/warning_letter/washington-fertility-center/10498cd4-2456-4653-a32e-70b5efd0254c)

## Related Officers

- [Shusheen A Alexander](https://www.keypedia.com/people/shusheen-a-alexander/dfc6f70c-c5e3-4076-8b0a-3fd433f2868a)

Company: https://www.keypedia.com/companies/washington-fertility-center/e6200eb5-1427-4213-b7e0-cadca336178a

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64