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

The FDA inspected Fertility Center of Southern California in Irvine, CA, from March 11-14, 2025. The inspection revealed a significant issue where a human cell, tissue, or cellular and tissue-based product (HCT/P) donor with a known risk factor for Creutzfeldt-Jacob Disease was improperly determined eligible, leading to the donation and cryopreservation of oocytes and tissues. This indicates a serious lapse in donor eligibility determination processes.