FDA 483 - Veterans Affairs Palo Alto Health Care System - February 13, 2025

An FDA inspection of Veterans Affairs Palo Alto Health Care System's Hospital Transfusion Service in Livermore, CA, revealed significant deficiencies in equipment management. The firm failed to regularly observe and calibrate equipment used in compatibility testing, storage, and distribution of blood and blood components, including centrifuges and refrigerators. These failures indicate a lack of adherence to established standard operating procedures for critical laboratory equipment.