FDA 483 - Washington Fertility Center - November 02, 2023

The FDA inspected Washington Fertility Center, a reproductive human tissue establishment in Annandale, VA, and found significant, often repeated, deficiencies. The firm failed to properly determine and document donor eligibility, inadequately screened and tested donors for communicable diseases like Zika, WNV, HIV, and HBV, and lacked appropriate written procedures for these critical processes. Additionally, documentation of eligibility determinations was flawed, and HCT/Ps not requiring full eligibility were improperly labeled.