FDA 483 - Dominion Fertility & Endocrinology - January 24, 2023

An FDA inspection of Dominion Fertility & Endocrinology, a reproductive human tissue establishment in Arlington, VA, revealed significant deficiencies in donor screening and testing procedures. The firm failed to adequately screen donors for communicable disease risks, including Zika virus and CJD/BSE, due to flawed medical history questionnaires. Additionally, the facility lacked established and maintained procedures for all FDA-required HCT/P donor testing.