# FDA 483 - Loma Linda University Center for Fertility and IVF - March 02, 2023

Source: https://www.keypedia.com/records/483/loma-linda-university-center-for-fertility-and-ivf/dede275f-4caf-40e8-a90a-47fb1ae2b524

> FDA 483 for Loma Linda University Center for Fertility and IVF on March 02, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Loma Linda University Center for Fertility and IVF
- Inspection Date: 2023-03-02
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Loma Linda University Center for Fertility and IVF, a reproductive fertility center in Loma Linda, CA, was cited for significant deficiencies in donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to adequately screen oocyte and semen donors for communicable diseases like West Nile Virus, syphilis, and Zika Virus, and lacked proper procedures for donor eligibility. Additionally, patient identifying information was found on records for anonymous donors.

## Related Documents

- [483 - 2023-03-02](https://www.keypedia.com/records/483/loma-linda-university-center-for-fertility-and-ivf/2e234745-7ab4-4b02-9afa-1270bfb45079)
- [483 - 2024-07-19](https://www.keypedia.com/records/483/loma-linda-university-center-for-fertility-and-ivf/fc764487-c484-48ea-88a1-b511d6eff997)

## Related Officers

- [Celeta S. Coves](https://www.keypedia.com/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.keypedia.com/companies/loma-linda-university-center-for-fertility-and-ivf/7e629e2d-3347-4655-a347-4347af81eda5

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6