FDA 483 - Harmonic Energetic Technologies Inc. - January 07, 2020

An FDA inspection of Harmonic Energetic Technologies Inc. in Liverpool, NY, revealed extensive deficiencies in their quality system for device manufacturing. The firm lacked established procedures for critical processes such as corrective and preventive actions, nonconforming product control, and medical device reporting. These findings indicate a broad failure to maintain essential quality system records and validate software, posing a high risk to product quality and patient safety.