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

Source: https://www.keypedia.com/records/warning_letter/california-ivf-fertility-center/f21195c8-8976-46fe-b838-bc49e5d017b3

> FDA WARNING_LETTER for California IVF Fertility Center on October 11, 2019. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: California IVF Fertility Center
- Inspection Date: 2019-10-11
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division II
- Summary: 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,

## Related Documents

- [483 - 2019-10-11](https://www.keypedia.com/records/483/california-ivf-fertility-center/8f614f2a-5f35-40d0-a1d8-0d394692dce9)
- [483 - 2020-10-07](https://www.keypedia.com/records/483/california-ivf-fertility-center/1815bd14-eed0-4134-a22e-8b84f924c828)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.keypedia.com/companies/california-ivf-fertility-center/c2670fe5-c56f-4d8a-b7e6-6bec4a2a8035

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-ii/a54ce137-326d-424b-ab5e-d8b8c28e8b47