FDA 483 - Center for Human Reproduction - July 20, 2022

Northwell Health Fertility in Manhasset, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in the screening and eligibility determination processes for HCT/P oocyte donors, including inadequate Zika Virus screening and untimely medical record reviews. Furthermore, the firm lacked established procedures for determining donor eligibility.