FDA 483 - Wisconsin Diagnostic Laboratories, LLC - June 25, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Person
ID · 9270cbac-c167-4662-9787-b81c63065c15