FDA 483 - Central Texas Veterans Health Care System - June 03, 2025

The FDA inspected Central Texas Veterans Health Care System, a hospital transfusion service in Temple, TX, from June 2-3, 2025. The inspection revealed a significant issue where the facility failed to consistently follow its written standard operating procedures for compatibility testing of blood and blood components and for error correction on quality control records. This indicates a breakdown in adherence to established quality management practices.