# Core Health and Fitness, LLC – FDA 483, Jul 30, 2026

Source: https://www.keypedia.com/records/483/core-health-and-fitness-llc/f681d4b0-d65c-45c4-a55b-703aaffe68de

> FDA 483 for Core Health and Fitness, LLC on July 30, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Core Health and Fitness, LLC
- Inspection Date: 2026-07-30
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Diversified Healthcare Development LLC in Independence, VA, a manufacturer, revealed two significant observations. The firm failed to adequately document procedures for controlling design and development changes, particularly for software, and did not properly monitor and control outsourced processes by failing to evaluate critical suppliers according to written procedures. These issues indicate deficiencies in the firm's quality system controls.

## Related Documents

- [483 - 2025-09-11](https://www.keypedia.com/records/483/core-health-and-fitness-llc/df5cb2e3-b5dd-4bfa-b4ca-494e0bd814f1) — date: September 11, 2025

## Related Officers

- [Shannon A. Gregory](https://www.keypedia.com/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64