FDA 483 - Terumo Medical Corporation - June 20, 2019

An FDA inspection of Terumo Medical Corporation in Elkton, MD, a device manufacturer, revealed significant deficiencies in quality system controls. Observations included inadequate control of nonconforming products, unestablished quality system procedures for risk evaluation, and failures in equipment calibration and maintenance protocols. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.