FDA 483 - Genesis Fertility & Reproductive Medicine - December 21, 2018

An FDA inspection of Genesis Fertility/Brooklyn Ivf/ Maimonides Medical Center in Brooklyn, NY, revealed significant deficiencies in donor screening procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to adequately screen donors for Zika Virus (ZIKV) risk factors and maintain complete records for communicable disease testing. These failures resulted in donors with identified ZIKV risk factors being deemed eligible, with their oocytes subsequently retrieved, fertilized, and transferred.