FDA 483 - Veterans Affairs Long Beach Health Care System - July 02, 2019

The FDA inspected VA Long Beach Healthcare System's Blood Bank (Transfusion Service) and found significant deficiencies in their quality system. Observations included failures to follow written SOPs for blood component handling and record-keeping, inadequate personnel training for critical tasks, and a lack of established and documented equipment maintenance and calibration procedures for essential storage units. These issues indicate a systemic breakdown in quality control and compliance.