FDA 483 - California Fertility Partners, A Medical Group, Professional Corporations - December 03, 2024

California Fertility Partners, A Medical Group Professional Corporations in Los Angeles, CA, was inspected from November 20 to December 3, 2024. The inspection revealed that the firm failed to adequately screen oocyte and semen donors for critical communicable disease agents and diseases, including HIV, Hepatitis B, Hepatitis C, and CJD, using insufficient donor history questionnaires. This lapse resulted in the determination of donor eligibility, recovery of reproductive tissues, and transfer of fertilized oocytes into recipients without proper screening.