InVia Fertility Specialists, PLLC – FDA Warning Letter, Feb 5, 2025

On June 13, 2025, the FDA issued a Warning Letter to InVia Fertility Specialists, PLLC, following an inspection from January 28 to February 5, 2025. The inspection documented significant violations of 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to test for communicable diseases:** An anonymous oocyte donor was not tested for HIV-1, HCV, and HBV, with HCT/Ps transferred to a recipient. (21 CFR 1271.85(a)) 2. **Inadequate donor screening:** Records for multiple anonymous oocyte and directed semen donors lacked documentation of medical history interviews and/or physical examinations. (21 CFR 1271.75(a)(1)) 3. **Failure to determine donor eligibility:** Approximately six anonymous and four directed oocyte donors from January 2023 to November 2024 had no documented eligibility determination, yet their HCT/Ps were transferred to recipients. (21 CFR 1271.50(a)) 4. **Improper labeling of HCT/Ps from ineligible donors:** HCT/Ps from two directed semen donors with reactive communicable disease tests were not labeled with required biohazard warnings. (2