MECTA Corporation – FDA 483, Jun 30, 2015

An FDA inspection of MECTA Corporation in Tualatin, OR, a medical device manufacturer, revealed three significant observations. The firm's procedures for design input were found to be inadequate due to conflicting software requirements, and design verification failed to confirm that design output met input requirements for their spECTrum Electro-Convulsive Therapy (ECT) devices. Additionally, procedures for routine equipment calibration were not adequately established, leading to undetected out-of-tolerance results for a final test fixture.