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

An FDA inspection of CARE for the Bay Area, a reproductive tissue establishment in Los Gatos, CA, revealed a significant deficiency in donor screening practices. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors, specifically by omitting critical questions regarding syphilis, gonorrhea, and chlamydia from their donor history questionnaires. This inadequacy led to the determination of ineligible donors as eligible, with reproductive tissues recovered and fertilized oocytes transferred to recipients.