# FDA 483 - Dominion Fertility & Endocrinology - December 06, 2024

Source: https://www.keypedia.com/records/483/dominion-fertility-endocrinology/8b5ea1e0-e968-4c7f-b0b9-97ff54f6930b

> FDA 483 for Dominion Fertility & Endocrinology on December 06, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dominion Fertility & Endocrinology
- Inspection Date: 2024-12-06
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: Dominion Fertility & Endocrinology in Arlington, VA, a reproductive human tissue establishment, was cited for failing to establish and maintain adequate procedures for testing HCT/P donors. Specifically, the firm's SOPs for donor eligibility determination did not include required communicable disease agent and disease (RCDAD) screening tests such as HBV, HIV-1, and HCV NAT testing. This was a repeat observation from a previous inspection, indicating a persistent and serious deficiency in donor screening protocols.

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## 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/dominion-fertility-endocrinology/f9649f49-2220-4f19-bc68-a03ca89628fc

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