# FDA 483 - Washington Fertility Center - October 23, 2025

Source: https://www.keypedia.com/records/483/washington-fertility-center/2bd3fa37-c3e9-4473-95d7-5feb35d526a9

> FDA 483 for Washington Fertility Center on October 23, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Washington Fertility Center
- Inspection Date: 2025-10-23
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Washington Fertility Center in Annandale, VA, a reproductive human tissue establishment, identified five observations related to deficiencies in donor eligibility determination, HCT/P labeling, and record-keeping. The firm failed to properly document donor eligibility before HCT/P transfer, did not label HCT/Ps from ineligible donors with required warnings, and lacked adequate procedures for communicating CMV test results. These issues indicate significant non-compliance with regulations for human cells, tissues, and cellular and tissue-based products.

## Related Documents

- [483 - 2021-11-17](https://www.keypedia.com/records/483/washington-fertility-center/4e8438b2-9683-497f-81d1-47ccfe160153)
- [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

- [La-tasha M. Gunter](https://www.keypedia.com/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

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