FDA WARNING_LETTER - Washington Fertility Center - November 02, 2023

On April 30, 2024, the FDA issued a Warning Letter to Washington Fertility Center following an inspection from October 11 to November 2, 2023. The inspection revealed significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. Failure to test anonymous oocyte donor specimens for HIV-1, HCV, and HBV by NAT method [21 CFR 1271.85(a)]. 2. Failure to screen reproductive donors by reviewing relevant medical records, including current medical history interviews and physical examinations [21 CFR 1271.75(a)]. This included incomplete Zika virus screening and outdated CJD risk factor questions. 3. Failure to determine donor eligibility based on complete screening and testing results; eligibility was determined before test results were received [21 CFR 1271.50(a)]. 4. Failure of a responsible person to determine and document donor eligibility based on mandatory screening and testing [21 CFR 1271.50(a)]. 5. Failure to establish and maintain procedures for testing, screening, and donor eligibility determination, including ZIKV screening and HBV NAT [21 CFR 1271.47(a)]. Obsolete questionnaires were also in use.