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InVia Fertility Specialists, PLLC, a biologics company specializing in reproductive cell and tissue products, failed to comply with federal regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) during an FDA inspection conducted in late January 2025. The company did not test specimens from anonymous oocyte donors for evidence of communicable disease agents including HIV-1, hepatitis C virus, and hepatitis B virus, and failed to screen donors by conducting required medical history interviews and reviewing relevant medical records for risk factors and clinical evidence of communicable diseases. Specifically, an anonymous oocyte donor was not tested for required communicable diseases before HCT/Ps were recovered and transferred to a recipient on April 15, 2024, and the donor's records lacked documentation of a medical history interview. These violations of 21 CFR 1271 posed potential risks to reproductive tissue recipients.