FDA 483 - Vitalant - February 07, 2025

Vitalant, a blood bank in Denver, CO, was cited for multiple deficiencies during an FDA inspection. Observations included failures in record-keeping for blood component processing and emergency transfusions, inadequate investigation of positive bacterial results in platelets, insufficient review of records before product release, and poor facility maintenance and donor screening privacy. These issues indicate significant concerns regarding quality control, documentation practices, and facility standards.