Kedrion S.p.A. – FDA 483, Jun 24, 2022

An FDA inspection of Kedrion S.p.A., a licensed biological drug manufacturer in Gallicano, Italy, revealed significant deficiencies in equipment maintenance, inspection, and process controls for their Kedbumin product. Observations included a lack of written procedures for equipment cleaning and maintenance, inadequate routine inspection of mechanical equipment, and unvalidated equipment for stopper placement, leading to concerns about product quality and purity. These issues suggest a need for comprehensive improvements in the firm's manufacturing and quality assurance systems.