NYU Langone Reproductive Specialists of New York – FDA 483, Sep 25, 2020

NYU Langone Reproductive Specialists of New York in Mineola, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed deficiencies in determining HCT/P donor eligibility, including premature eligibility determinations before communicable disease test results were finalized and an inadequate screening questionnaire for Zika virus risk factors. Additionally, donor specimens for communicable disease testing, specifically for West Nile Virus, were not collected within the required timeframes.