FDA 483 - CCRM Fertility Northern Virginia - February 11, 2022

CCRM Fertility Northern Virginia, a reproductive human tissue establishment in Vienna, VA, was cited for deficiencies in its donor screening processes. The inspection revealed that donor medical history interview questionnaires and established procedures for HCT/P donor screening used gender-specific language for Zika Virus risk factors, failing to adequately screen all potential donors for communicable diseases. This indicates a significant oversight in ensuring comprehensive donor eligibility.