FDA 483 - Fertility Center of Southern California - March 14, 2025

The FDA inspected Fertility Center of Southern California, a reproductive human tissue establishment, and identified a critical failure in donor eligibility determination. A directed donor with a documented risk factor for Creutzfeldt-Jacob Disease was improperly deemed eligible by the Medical Director, leading to the donation of oocytes and cryopreserved tissues. This indicates a significant lapse in the firm's donor screening and eligibility processes.