CCRM Fertility Northern Virginia – FDA 483, Feb 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.
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ID · b2aa70b8-4b51-4497-a6e3-59e7a7c4efad
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