Dominion Fertility & EndocrinologyDecember 6, 2024

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

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Record Details

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.

Company: Dominion Fertility & Endocrinology
Inspection Date: December 6, 2024
Product Type: Biologics
Office: Baltimore District Office
Person: La-tasha M. Gunter

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ID · fc6838db-b447-4c5c-bf6d-28c7bdfc6343