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

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.