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Sperm Bank, Inc. dba Fertility Center of California, a biologics firm handling human cells and tissues for reproductive purposes, failed to comply with FDA regulations for human cell, tissue, and cellular products (HCT/Ps) under 21 CFR Part 1271. During a June 2024 inspection, the FDA documented significant deviations including failure to perform required communicable disease testing on anonymous and directed reproductive donors, specifically noting that repeat semen donors were not tested for West Nile Virus using FDA-licensed nucleic acid tests during the required June-October testing periods. The violations represented critical gaps in donor screening and eligibility determination processes that could compromise product safety and recipient health.