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

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.