FDA 483 - Department of Veterans Affairs Medical Center - July 08, 2024

The FDA issued a Form 483 to the Department of Veterans Affairs Medical Center in Washington, DC, following an inspection of its Hospital Blood Bank/Transfusion Service. The inspection revealed two significant observations related to inadequate record-keeping for emergency blood transfusions and deficiencies in standard operating procedures and quality control for blood product storage coolers, including out-of-specification temperatures.