FDA 483 - University of Chicago Hospitals - July 17, 2025
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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.
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ID · 0c3f688c-9b50-4e6c-a908-30f43c44309a