FDA 483 - Department of Defense - Navy - February 10, 2022

The FDA inspected the Department of the Navy, Fort Belvoir Community Hospital's Transfusion Services and identified deficiencies in the validation and standardization of equipment used for blood and blood component handling. The hospital failed to perform annual validations for blood transport coolers, had incomplete or unclear procedural steps, and lacked required signatures on validation plans. These findings indicate a need for improved control over critical equipment and documentation practices.