FDA 483 - NYU Langone Reproductive Specialists of New York - September 30, 2021

An FDA inspection of NYU Langone Reproductive Specialists of New York in Mineola, NY, revealed significant deficiencies in their human cell, tissue, and cellular and tissue-based product (HCT/P) operations. The firm failed to establish and maintain adequate procedures for screening and determining the eligibility of oocyte donors, including for infectious disease risks like ZIKV and West Nile Virus. Additionally, HCT/Ps for which donor eligibility requirements were not met were not prominently labeled with appropriate warning statements prior to release or transfer.