FDA 483 - Stanford Blood Center - November 26, 2024

Stanford Blood Center in Palo Alto, CA, was inspected and cited for significant deficiencies in its quality systems. Observations included failure to verify system changes, non-adherence to deviation investigation procedures, inadequate equipment maintenance and validation protocols, and non-compliance with production control and donor screening documentation. These issues indicate a lack of robust controls over critical blood product manufacturing and donor qualification processes.