483
New York CryoFDA 483 - New York Cryo - March 21, 2024
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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.
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ID · d7f52016-4169-4562-9b05-b25b6f623f36