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

Source: https://www.keypedia.com/records/483/harmonic-energetic-technologies-inc/22d74364-44c7-40d5-954c-de036ec1447e

> FDA 483 for Harmonic Energetic Technologies Inc. on March 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harmonic Energetic Technologies Inc.
- Inspection Date: 2025-03-07
- Product Type: device
- Office Name: New York District Office
- Summary: 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.

## Related Documents

- [483 - 2020-01-07](https://www.keypedia.com/records/483/harmonic-energetic-technologies-inc/8e4b731e-db63-411d-b488-2de46e7e95df)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/harmonic-energetic-technologies-inc/e9d1cdf8-ae01-4a91-a9f4-a4db954fd54e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d