FDA 483 - I.T.S. GmbH - November 16, 2023

An FDA inspection of I.T.S. GmbH, a medical device manufacturer in Lasnitzhohe, Steiermark, Austria, revealed significant deficiencies in its quality system. Observations included inadequate corrective and preventive action procedures, issues with equipment calibration and identification, and incomplete device history records related to labeling. These findings indicate a need for comprehensive improvements in the firm's quality management processes.