FDA Hits Reliance Mobility for Device History Records

Reliance Mobility erred on device history records, design controls and complaint procedures, the FDA said in a Form 483.

The FDA issued the form after an April inspection of its Columbia, Tennessee, facility. The agency found the firm had no design history file or device master records for two of its speech generating devices, and it lacked procedures for design control.

The company’s device history records for the same devices did not include the labeling for each production unit, manufacture dates, final acceptance records, or documentation of the software version downloaded into each device.