The Metz Dental Laboratory in Columbus, Ohio drew a Form 483 for problems observed in a May 16-22 inspection, including a lack of design validation procedures.
The facility failed to verify that the design output met design input requirements, the agency said. The company also lacked a design history file and a device master record for the Metz Appliance device.
The FDA also noted the company’s device history records did not include all of the labeling applied to each device. The agency also found inadequate document control procedures.
For example, the usage and home care instruction and seating instructions for the Metz Appliance were not included in the device history files.