FDA 483 - New York Cryo - March 21, 2024

An FDA inspection of New York Cryo, a reproductive human tissue facility in Great Neck, NY, revealed a critical lapse in donor eligibility determination. The firm failed to properly screen a directed semen donor who tested positive for a high-risk factor, subsequently distributing cryopreserved semen from this ineligible donor. This indicates a serious deviation from established donor screening and eligibility procedures.