Terumo Cardiovascular Systems Corporation – FDA 483, May 18, 2004

Terumo Cardiovascular Systems Corp., a medical device manufacturer in Ann Arbor, Michigan, received an FDA Form 483 following an inspection conducted from May 10 to May 18, 2004. The document outlines significant observations regarding the company's adherence to medical device quality system regulations.

Key issues identified span several critical areas. In Management Controls, the FDA noted an inadequate and ineffective quality system, including insufficient quality audit procedures, lack of regular audits, and employees unfamiliar with the company's quality policy. Design Controls revealed unresolved discrepancies post-design validation, incomplete risk analyses, and unapproved design plans.

Corrective and Preventive Actions (CAPA) were cited for incomplete procedures, failure to assess complaints for Medical Device Report (MDR) reportability, untimely processing of numerous complaints, and lack of verification for corrective actions. Furthermore, Production and Process Controls had deficiencies such as unvalidated processes, improper document control for changes, uninvestigated environmental control excursions, uncalibrated equipment, delayed employee training, and inadequate product storage controls.

The FDA expects Terumo Cardiovascular Systems Corp. to respond to these observations with detailed corrective actions and a plan for their implementation to ensure compliance with federal regulations governing medical device manufacturing.