FDA 483 - CARE for the Bay Area - July 31, 2025

An FDA inspection of CARE for the Bay Area, a reproductive establishment in Los Gatos, CA, revealed critical deficiencies in donor screening practices. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors, leading to the use of ineligible donors. This lapse resulted in the transfer of reproductive tissues from affected donors to recipients, with additional affected tissues currently stored at the facility.