FDA 483 - Mak-System Corp. - August 11, 2023

An FDA inspection of Mak-System Corp. in Des Plaines, IL, a manufacturer and initial importer of ePROGESA blood bank software, revealed significant deficiencies in its quality system. The firm was cited for inadequate procedures for complaint handling, which was a repeat observation, and for failing to adequately establish and document corrective and preventive actions. These issues indicate a systemic lack of rigor in managing quality processes.