Fertility Center of Southern CaliforniaMarch 14, 2025

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

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Record Details

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.

Company: Fertility Center of Southern California
Inspection Date: March 14, 2025
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Irina Gaberman (Investigator)

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ID · 202a2f76-ec1a-44b2-8a21-10fa7c5de9a1