FDA 483 - University Fertility Center - April 03, 2023

An FDA inspection of University Fertility Laboratory, Inc. in Torrance, CA, identified a repeat observation concerning the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to include the required "NOT EVALUATED FOR INFECTIOUS SUBSTANCES" warning on IVF laboratory documents for multiple anonymous oocyte donors. This indicates a deficiency in ensuring proper labeling for HCT/Ps not subject to donor eligibility determination.