# FDA 483 - JoGo Health - July 30, 2024

Source: https://www.keypedia.com/records/483/jogo-health/57c591f5-b982-4f32-bd3a-0480f424563e

> FDA 483 for JoGo Health on July 30, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JoGo Health
- Inspection Date: 2024-07-30
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of JoGo Health in Bridgewater, NJ, a specification developer for the JOGO-GX biofeedback device, revealed significant deficiencies in their quality system. The firm failed to document software validation results, establish procedures for finished device acceptance, and implement adequate personnel training programs. These observations indicate fundamental gaps in ensuring product quality and compliance.

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/jogo-health/8e0a27ba-0e62-4e41-8c6c-1a840d27f5e3

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248