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

Source: https://www.globalkeysolutions.net/records/483/dominion-fertility-endocrinology/fc6838db-b447-4c5c-bf6d-28c7bdfc6343

> 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: Baltimore District Office
- Summary: Dominion Fertility & Endocrinology in Arlington, VA, was inspected from December 5-6, 2024, regarding its reproductive human tissue operations. The inspection revealed a significant issue where the firm failed to establish and maintain adequate procedures for testing HCT/P donors, specifically regarding the inclusion of required communicable disease agent testing in their SOPs. This indicates a serious lapse in donor eligibility determination processes.

## Related Documents

- [483 - 2023-01-24](https://www.globalkeysolutions.net/records/483/dominion-fertility-endocrinology/f05f2db2-f94f-4571-b8f9-37115a3f5af5)

## 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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa