FDA 483 - Terumo Cardiovascular Systems Corp - September 25, 2017

An FDA inspection of Terumo Cardiovascular Systems Corp in Ashland, MA, a manufacturer of Cardiovascular Procedure Kits, identified two significant observations. The firm was cited for inadequate complaint file maintenance, specifically lacking defined processing timeframes and having complaints open for extended periods. Additionally, the inspection found deficiencies in establishing and adhering to equipment preventative maintenance schedules for critical sealing equipment.