FDA 483 - Montefiore's Institute for Reproductive Medicine and Health - August 16, 2021

An FDA inspection of Montefiore's Institute for Reproductive Medicine and Health in Hartsdale, NY, revealed significant deficiencies in donor screening procedures for communicable diseases. The firm failed to adequately screen oocyte and semen donors for Zika virus due to incomplete medical history forms. Additionally, the facility's standard operating procedures and forms for Zika virus donor eligibility were found to be incorrect and not adequately reviewed or revised.