# FDA 483 - Core Health and Fitness, LLC - September 11, 2025

Source: https://www.globalkeysolutions.net/records/483/core-health-and-fitness-llc/df5cb2e3-b5dd-4bfa-b4ca-494e0bd814f1

> FDA 483 for Core Health and Fitness, LLC on September 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Core Health and Fitness, LLC
- Inspection Date: 2025-09-11
- Product Type: device
- Office Name: Baltimore District Office
- Summary: Diversified Healthcare Development LLC, a manufacturer of Korebalance and KoreSway devices in Independence, VA, was cited for six significant deficiencies during an FDA inspection. The firm failed to adequately implement risk analysis, validate device software, establish equipment calibration procedures, conduct management reviews, perform quality audits, and control suppliers. These issues indicate systemic problems in their quality system.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/core-health-and-fitness-llc/5ecfbd32-0c18-4862-8c76-9488fbf9273e

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa