FDA Cites Remote Technologies for Faulty Complaint Handling, Calibration
The FDA issued Remote Technologies a Form 483 after an inspection of its Greenwich, Connecticut facility identified poor complaint investigations and a failure to properly calibrate equipment.
The agency’s investigator found that from January 2015 to the present, four complaints were filed against the firm’s mobile X-ray exposure switch. For one complaint about the device’s transmitter, the firm concluded the fault was “bad battery terminal,” but failed to elaborate on what made the battery terminal “bad” or investigate further.
In addition, the firm’s calibration procedures were found to be inadequate. The procedures established that the facility’s multimeters used for in-process and finished product electrical testing did not require calibration.
Multimeters require periodic calibration unless they are replaced with a new unit before the calibration due date, the FDA said.