FDA 483 - Michael D. Williams, D.D.S., P.A. - March 31, 2022

Michael D. Williams, D.D.S., P.A. in Davie, FL, a medical device manufacturer, was inspected regarding its anti-snoring mouthpiece. The inspection revealed significant deficiencies in design control, production process control, purchasing controls, and corrective and preventive actions. Many of these issues were repeat observations from previous inspections, indicating a systemic failure to address quality system requirements.