# FDA 483 - Medical Energy, Inc. - May 17, 2023

Source: https://www.globalkeysolutions.net/records/483/medical-energy-inc/750b1588-a590-4935-a9e8-8a18ac7fdef8

> FDA 483 for Medical Energy, Inc. on May 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Energy, Inc.
- Inspection Date: 2023-05-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Medical Energy, Inc. in Pensacola, FL, a manufacturer of medical devices, revealed four significant quality system deficiencies. These included inadequate procedures for complaint handling, supplier evaluation, design validation, and document control. Notably, three of the four observations were repeats from a 2016 inspection, indicating a persistent lack of corrective action.

## Related Officers

- [Natasha R. Johnson](https://www.globalkeysolutions.net/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.globalkeysolutions.net/companies/medical-energy-inc/208596ee-6736-4537-b9a7-4183d0ed127b

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6