FDA 483 - U.S. Dept. of Veterans Affairs, Northport VA Medical Center - May 18, 2021

The FDA inspected the U.S. Dept. of Veterans Affairs, Northport VA Medical Center Blood Bank, revealing significant deficiencies in record-keeping practices. The facility failed to maintain adequate processing and general records, particularly concerning invalidated test results and the concurrent documentation of blood product distribution. These issues indicate a lack of control over critical blood bank operations and raise concerns about data integrity.