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Washington Fertility Center, a biologics manufacturer specializing in reproductive cells and tissues, failed to comply with federal regulations for human cells, tissues, and cellular products (HCT/Ps) under 21 CFR Part 1271. Specific violations included the failure to test donor specimens for communicable diseases such as HIV-1, HCV, and HBV using nucleic acid testing methods, and the failure to properly screen donors through current medical history interviews and physical examination reports as required by federal law. These deviations were documented during an FDA inspection conducted between October and November 2023 at the company's Annandale, Virginia facility.