FDA Cites Neurotron for Instructions, Calibration Issues

Neurotron landed an FDA Form 483 for problems with its product instructions and failure to calibrate equipment.

The agency’s April inspection of the devicemaker’s Pasadena, Md., facility, determined the company’s repair order instructions for its products were inadequate and none of the 10 service reports reviewed documented the individuals who serviced the device or the test and inspection data.

The FDA also faulted the device manufacturer on its calibration procedures. The firm failed to follow the procedures on calibration, as stated in its SOPs for measuring and monitoring equipment.