# FDA 483 - Aurora St. Luke's Medical Center of Aurora Health Care Metro, Inc. - June 24, 2025

Source: https://www.globalkeysolutions.net/records/483/aurora-st-lukes-medical-center-of-aurora-health-care-metro-inc/97002159-368b-485b-822c-226324eced0a

> FDA 483 for Aurora St. Luke's Medical Center of Aurora Health Care Metro, Inc. on June 24, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurora St. Luke's Medical Center of Aurora Health Care Metro, Inc.
- Inspection Date: 2025-06-24
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: Aurora St. Luke's Medical Center, a hospital blood bank in Milwaukee, WI, was cited for deficiencies in its blood and blood component distribution procedures. The firm failed to establish adequate written standard operating procedures, specifically regarding notification of nursing staff for blood product release and dispatch. This led to unattended blood units being transfused and a failure to investigate related incidents.

## Related Officers

- [Kenneth L. Smalls](https://www.globalkeysolutions.net/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)

Company: https://www.globalkeysolutions.net/companies/aurora-st-lukes-medical-center-of-aurora-health-care-metro-inc/af02fd6f-78d4-40b8-b2b5-3d005f80ed3a

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d