FDA 483 - UNC Healthcare/Fertility - July 20, 2022

An FDA inspection of UNC Healthcare/Fertility in Raleigh, NC, identified a significant deficiency related to donor eligibility procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). The firm failed to establish and maintain adequate procedures for screening and determining HCT/P donor eligibility, specifically lacking comprehensive steps, questionnaire guidance, and clarity on who can determine eligibility. This indicates a moderate severity issue concerning HCT/P donor screening practices.