FDA 483 - University of Miami Infertility Center - December 21, 2023

The University of Miami Infertility Center, a reproductive tissue establishment in Miami, FL, received a Form 483 for failing to adequately screen oocyte and sperm donors for communicable diseases. The firm's standard operating procedures for Zika Virus (ZikV) screening were found to be deficient, as they only required screening if south Florida was designated an active ZikV transmission area by the CDC. This indicates a significant lapse in donor safety protocols.