FDA 483 - Csl Plasma, Inc. - February 26, 2025

CSL Plasma, Inc. in Minneapolis, MN, a plasmapheresis center, was cited for inadequate equipment standardization and calibration. Specifically, donor screening procedures for vital sign measurement did not follow the user manual requirements for an automated vital sign machine, leading to improper thermometer and blood pressure cuff placement. This indicates a lack of adherence to established protocols for critical donor screening activities.