FDA 483 - Iotamotion Inc - September 12, 2024

An FDA inspection of Iotamotion Inc, a medical device manufacturer in Vadnais Heights, MN, revealed a significant lapse in quality control. The firm failed to adequately examine labeling for accuracy before release, leading to the shipment of mislabeled medical devices. This indicates a breakdown in adherence to their own established work instructions for visual inspection.