KEDPLASMA LLC – FDA 483, Jul 30, 2026

KEDPLASMA LLC in Goodyear, AZ, a plasmapheresis collection center, was cited for three observations during an FDA inspection. The findings included failures to adequately explain plasmapheresis risks to donors, non-adherence to standard operating procedures during donor physical examinations, and deficiencies in the scheduled calibration and preventative maintenance of collection equipment. These issues indicate a need for improved procedural compliance and equipment management.