FDA 483 - Harmonic Energetic Technologies Inc. - March 07, 2025

Harmonic Energetic Technologies Inc. in Liverpool, NY, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in design control, including a lack of design validation and established procedures for their LIFE System Pro Plus device. Additionally, the firm failed to adequately document complaint investigations and provide required Unique Device Identifier (UDI) information to the Global Unique Device Identification Database.