FDA 483 - Loma Linda University Center for Fertility and IVF - July 19, 2024

An FDA inspection of Loma Linda University Center for Fertility and IVF revealed significant deficiencies in donor eligibility determination for HCT/Ps, including a repeat observation for failing to determine donor eligibility based on screening and testing results. The firm was cited for not properly labeling HCT/Ps from ineligible donors, lacking adequate procedures for donor testing and screening, and failing to maintain proper documentation for testing laboratories and donor eligibility determinations. These issues indicate systemic problems in ensuring the safety and eligibility of human cells, tissues, and cellular and tissue-based products.