FDA 483 - Columbia University Fertility Center - December 20, 2024

Columbia University Fertility Center, a human reproductive tissue establishment in New York, NY, was cited for multiple deficiencies during an FDA inspection. Observations included failures in timely communicable disease testing for donors, incorrect donor eligibility determinations, and inadequate labeling of reproductive tissues from ineligible donors. The firm also lacked a standard operating procedure for releasing HCT/Ps from CMV-reactive donors.