FDA WARNING_LETTER - California IVF Fertility Center - October 11, 2019

On February 26, 2020, the FDA issued a Warning Letter to California IVF Fertility Center following an inspection from October 4-11, 2019. 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 for communicable disease agents:** Approximately (b)(4) oocyte donors and (b)(4) semen donors were not tested for West Nile Virus (WNV) using an FDA-licensed Nucleic Acid Test (NAT) between June 1 and October 31 since November 1, 2017, as required by 21 CFR 1271.85(a). 2. **Inadequate donor screening:** The firm's Donor Infectious Disease Risk Questionnaire lacked screening for critical risk factors for relevant communicable disease agents (RCDADs), including WNV, Zika Virus (ZIKV), and specific travel/transfusion history (e.g., blood transfusions in France, ZIKV exposure within 6 months), violating 21 CFR 1271.75(a)(l). 3. **Failure to establish and maintain procedures:** The firm lacked written procedures for screening and testing for ZIKV and WNV, and for NAT testing for HIV, HBV,