FDA 483 - University Fertility Center - August 10, 2021

An FDA inspection of University Fertility Laboratory, Inc. in Torrance, CA, revealed two repeat observations concerning the handling and labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps until donor eligibility was determined and did not properly label HCT/Ps that did not meet donor eligibility requirements with appropriate warning statements. These deficiencies indicate a serious lack of compliance with regulatory standards.