FDA 483 - Terumo Cardiovascular Systems Corporation - December 09, 2005

An FDA inspection of Terumo Cardiovascular Systems Corporation, a medical device manufacturer located in Ann Arbor, MI, was conducted from December 6 to December 9, 2005. The inspection resulted in the issuance of an FDA Form 483, highlighting three significant observations related to the company's quality system and regulatory compliance. The primary issue identified was the delayed submission of Medical Device Reports (MDRs). Out of 17 reviewed reports concerning device malfunctions with the potential for serious injury or death, 14 were not filed within the required 30-day timeframe, with delays extending up to 80 days.

Additionally, the firm's complaint handling process was found to be incomplete. A specific complaint regarding an APS Platform System's performance was not thoroughly evaluated to determine the potential impact of a component failure on products already distributed. Lastly, deficiencies were noted in employee training, with two training records being incomplete. Personnel responsible for critical quality functions, such as Medical Device Reporting and Field Service, had not received required training on essential quality system procedures and manuals.

Terumo Cardiovascular Systems Corporation committed to addressing these observations and implementing corrective actions within 30 days to ensure adherence to regulatory standards for medical device manufacturing.