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

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.