# FDA 483 - Wisconsin Diagnostic Laboratories, LLC - June 25, 2025

Source: https://www.globalkeysolutions.net/records/483/wisconsin-diagnostic-laboratories-llc/9270cbac-c167-4662-9787-b81c63065c15

> FDA 483 for Wisconsin Diagnostic Laboratories, LLC on June 25, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wisconsin Diagnostic Laboratories, LLC
- Inspection Date: 2025-06-25
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Wisconsin Diagnostic Laboratories, LLC's Blood Bank and Transfusion Services in Milwaukee, WI, identified a significant record-keeping deficiency. The firm failed to maintain records, including physician signatures, for emergency transfusions, with multiple instances of blood products released without proper documentation. Furthermore, the firm's procedure allows non-physician staff to sign for emergency released blood products, indicating a systemic issue with compliance.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/wisconsin-diagnostic-laboratories-llc/3b95ab5c-221e-4841-b9a0-b0e64de3757a

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