FDA 483 - Parkview Health Laboratories - January 30, 2025

An FDA inspection of Parkview Health Laboratories' Hospital Blood Bank in Fort Wayne, IN, revealed a significant deficiency in record-keeping for emergency transfusions. The facility failed to maintain records, including physician signatures, for numerous emergency and massive transfusion events, instead documenting verbal consents or nurse signatures. This indicates a serious lapse in ensuring proper authorization and documentation for critical blood product releases.