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Palm Beach Fertility Center, a reproductive medicine practice, failed to comply with FDA regulations for human cells, tissues, and cellular products (HCT/Ps) under 21 CFR Part 1271. During a May-June 2022 inspection, the FDA identified critical deviations including the failure to determine donors ineligible when they disclosed communicable disease risk factors—specifically, directed semen donors who reported sexual contact with men within five years and extended residence in Europe during the specified timeframe were incorrectly classified as eligible, and their samples were processed and recovered. The facility also failed to adequately screen donors by reviewing relevant medical records for documented risk factors and clinical evidence of communicable disease agents as required by federal regulations.