# FDA 483 - Dental Health Associates Of Madison, Ltd - September 03, 2024

Source: https://www.keypedia.com/records/483/dental-health-associates-of-madison-ltd/22d0d187-f759-4fe5-8491-f1798e808cf2

> FDA 483 for Dental Health Associates Of Madison, Ltd on September 03, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dental Health Associates Of Madison, Ltd
- Inspection Date: 2024-09-03
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Dental Health Associates Of Madison, Ltd in Fitchburg, WI, a manufacturer of Class II anti-snoring medical devices, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, including a complete lack of established quality policy, objectives, management review procedures, a quality plan, and numerous essential quality system procedures and instructions. These findings indicate a fundamental absence of a compliant quality system.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/dental-health-associates-of-madison-ltd/c5da4510-fd03-4e6b-bd08-0dce58ab6521

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d