Iotamotion IncSeptember 12, 2024

FDA 483 - Iotamotion Inc - September 12, 2024

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Iotamotion Inc

Record Details

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.

Company: Iotamotion Inc
Inspection Date: September 12, 2024
Product Type: Device
Office: Minneapolis District Office
People: Lashawn M. Elam
Clifford F. Long

Open in Dashboard

ID · c9281e46-0f18-4fdb-a634-df404cc3eea8