FDA 483 - Transtracheal Systems, Inc. - September 17, 2020

An FDA inspection of Transtracheal Systems, Inc. in Englewood, CO, a medical device manufacturer, from September 2-17, 2020, revealed significant deficiencies across multiple quality system areas. The firm was cited for inadequate process validation, corrective and preventive actions, complaint handling, labeling controls, acceptance activities, device history records, purchasing controls, and document control. Several of these observations were repeat findings, indicating persistent issues with the firm's quality management system.