FDA 483 - University Fertility Center - January 17, 2025

An FDA inspection of University Fertility Laboratory, Inc. in Torrance, CA, an HCT/P Reproductive Establishment, revealed two significant observations. The firm failed to adequately test anonymous oocyte donors for relevant communicable disease agents, specifically Hepatitis C Virus, before determining donor eligibility and transferring oocytes. Additionally, the firm did not ensure its contract testing laboratory complied with applicable Current Good Tissue Practice requirements, lacking a formal agreement for required donor testing.