FDA 483 - University of Miami Infertility Center - September 09, 2022

The FDA inspected the University of Miami Infertility Center and identified significant deficiencies related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to ensure donors were free of communicable disease agents, determined donor eligibility prematurely, and did not properly label HCT/Ps from ineligible donors with biohazard warnings. Two of these critical observations were repeat findings from a prior inspection, indicating persistent non-compliance.