FDA 483 - Vitalant Reference and Transfusion Service - September 13, 2019

An FDA inspection of ITxM, a blood bank in Pittsburgh, PA, identified one observation related to the maintenance of equipment used for storing blood and blood products. The firm failed to keep refrigerator shelves and separators clean and orderly, with detached labels creating a potential for product identification mix-ups. This indicates a moderate concern regarding facility cleanliness and potential for errors in product handling.