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

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.