FDA 483 - CNY Fertility, PLLC - March 17, 2022

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.