FDA 483 - Vitalant - January 10, 2025

Vitalant in Chico, CA, was inspected from January 7-10, 2025, revealing deficiencies in their standard operating procedures for blood collection. Specifically, an SOP for automated/apheresis collections was found inadequate for addressing certain alarms and failed to require documentation of non-recoverable alarms. This indicates a lapse in established procedures for critical operational aspects.