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

Source: https://www.globalkeysolutions.net/records/483/university-of-chicago-hospitals/0c3f688c-9b50-4e6c-a908-30f43c44309a

> FDA 483 for University of Chicago Hospitals on July 17, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Chicago Hospitals
- Inspection Date: 2025-07-17
- Product Type: other
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Gabryelle J. Solverud](https://www.globalkeysolutions.net/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)

Company: https://www.globalkeysolutions.net/companies/university-of-chicago-hospitals/16e124cf-2450-4465-ab37-63b2f380dfa9

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669