FDA 483 - Montefiore's Institute for Reproductive Medicine and Health - May 03, 2019

An FDA inspection of Montefiore's Institute for Reproductive Medicine and Health in Hartsdale, NY, revealed two significant observations related to human reproductive tissue. The firm failed to properly determine and document the eligibility of oocyte donors, specifically by not testing for West Nile Virus. Additionally, the firm's standard operating procedures for egg donor screening were not revised to include seasonal West Nile Virus testing.