FDA 483 - Department of Veterans Affairs Medical Center - August 27, 2021

The FDA inspected the Department of Veterans Affairs Medical Center, Blood Bank in Washington, DC, and issued a Form 483 with two observations. The inspection revealed deficiencies in monitoring laboratory test procedures and instruments, specifically regarding out-of-range room temperatures in the blood bank. Additionally, the firm failed to properly store supplies and reagents, with instances of mislabeled shelves and expired compatibility testing cards.