FDA 483 - Tecomet, Inc. - November 15, 2019

An FDA inspection of Tecomet, Inc. in Boulder, CO, a contract medical device manufacturer, revealed significant quality system deficiencies. The firm failed to adequately validate processes and software, and lacked proper procedures for corrective and preventive actions, complaint handling, nonconforming product control, acceptance activities, and quality audits. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.