FDA 483 - Terumo Cardiovascular Systems Corporation - September 28, 2012

Terumo Cardiovascular Systems Corporation in Ann Arbor, MI, was cited for four significant issues during an FDA inspection. The firm failed to submit premarket notifications for significant device changes, reported numerous Medical Device Reports (MDRs) late, lacked adequate procedures for broker-purchased components, and had insufficient procedures for controlling nonconforming products related to environmental monitoring deviations. These observations indicate serious deficiencies in regulatory compliance and quality system management.