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Conceive Fertility Center, a fertility clinic handling human reproductive cells and tissues (biologics), failed to adequately screen egg and sperm donors for communicable disease risks as required under 21 CFR 1271.75(a)(1). During a June 2025 FDA inspection, the agency identified that the facility's Donor Medical History Interview Form—used to evaluate approximately 61 anonymous egg donors, 40 directed egg donors, and 79 directed sperm donors between January 2022 and June 2025—was missing critical screening questions, timeframes, and deferral periods necessary to assess donors' risk factors for HIV, hepatitis B, hepatitis C, and other relevant communicable diseases. The violations represented significant deviations from the federal regulations governing human cells, tissues, and cellular products under Section 361 of the Public Health Service Act.