FDA 483 - University of Chicago Hospitals - July 17, 2025

The FDA inspected University of Chicago Hospitals in Chicago, focusing on reproductive services. The inspection revealed a significant issue with the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically the failure to apply required warning statements regarding infectious substances and communicable disease risks before transfer. This indicates a lapse in ensuring the safety and proper handling of these critical biological materials.