FDA 483 - CSL Plasma Inc. - February 01, 2024

CSL Plasma Inc. in Dallas, TX, a plasmapheresis center, was cited for failing to follow its written standard operating procedures for the storage and disposition of blood and blood components. Specifically, units from donors who tested reactive for RTTIs were found to remain in "inventory" status, indicating they were retrievable despite being unsuitable. This represents a significant lapse in quality control and adherence to internal procedures for managing potentially unsafe blood products.