FDA 483 - Rockefeller Fertility Center - November 05, 2021

Rockefeller Fertility Center in New York, NY, was inspected regarding its human reproductive tissue operations, specifically oocyte donors. The inspection revealed significant deficiencies in screening donors for communicable disease risks, particularly Zika Virus, and a failure to establish and maintain adequate donor eligibility procedures. These issues indicate a lack of proper controls for ensuring donor safety and product quality.