FDA 483 - Yale Center For Reproductive Medicine & Infertility - September 23, 2020

An FDA inspection of Yale Center For Reproductive Medicine & Infertility in Orange, CT, revealed a significant deficiency in donor screening practices. The firm failed to test four anonymous oocyte donors for West Nile Virus between June and October 2018, despite determining them eligible to donate and subsequently retrieving and fertilizing their oocytes. This lapse in communicable disease agent testing raises concerns about the safety of human reproductive tissue.