# FDA 483 - Dominion Fertility & Endocrinology - January 24, 2023

Source: https://www.globalkeysolutions.net/records/483/dominion-fertility-endocrinology/f05f2db2-f94f-4571-b8f9-37115a3f5af5

> FDA 483 for Dominion Fertility & Endocrinology on January 24, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dominion Fertility & Endocrinology
- Inspection Date: 2023-01-24
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Dominion Fertility & Endocrinology, a reproductive human tissue establishment in Arlington, VA, revealed significant deficiencies in donor screening and testing procedures. The firm failed to adequately screen donors for communicable disease risks, including Zika virus and CJD/BSE, due to flawed medical history questionnaires. Additionally, the facility lacked established and maintained procedures for all FDA-required HCT/P donor testing.

## Related Documents

- [483 - 2024-12-06](https://www.globalkeysolutions.net/records/483/dominion-fertility-endocrinology/fc6838db-b447-4c5c-bf6d-28c7bdfc6343)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/dominion-fertility-endocrinology/f9649f49-2220-4f19-bc68-a03ca89628fc

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