FDA Writes Up New York Manufacturer for Quality Failures

The FDA has hit Liverpool, N.Y.-based devicemaker Harmonic Energetic Technologies with a Form 483 for inadequate quality management.

The company makes the LIFE system, a biofeedback device intended to reduce stress and relax muscles using an algorithm that provides feedback to the patient.

In an inspection of Harmonic’s manufacturing facility, the FDA investigator found that there was no device history record and that the firm lacked written process control procedures.