FDA 483 - KOFU FACTORY OF TERUMO CORP. - March 21, 2023

KOFU FACTORY OF TERUMO CORP. in Nakakoma-Gun, Japan, a sterile drug manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic processing areas, environmental controls, and quality control procedures. These issues indicate a lack of adequate measures to prevent contamination and ensure drug product sterility and quality.