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

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.