FDA 483 - Terumo Cardiovascular Systems Corp - January 17, 2013

An FDA inspection of Terumo Cardiovascular Systems Corp in Ashland, MA, a manufacturer and repacker/relabeler of medical devices, revealed three significant observations. The firm failed to adequately maintain device history records, establish proper labeling control procedures, and implement corrective and preventive action procedures. These issues indicate deficiencies in the firm's quality system regarding documentation and complaint handling.