FDA 483 - CNY Fertility, PLLC - March 17, 2022
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An FDA inspection of CNY Fertility Center in Latham, NY, a human reproductive tissue establishment, revealed that human cells, tissues, and cellular and tissue-based products (HCT/Ps) were not kept in quarantine until donor-eligibility determinations were completed. Specifically, multiple oocyte and semen donors were not fully tested for infectious diseases, including West Nile Virus, before their HCT/Ps were used or banked. This indicates a failure in critical donor screening and product safety protocols.
ID · 280ba3c3-faad-4226-b55a-99c8fb5453ae