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

Source: https://www.globalkeysolutions.net/records/483/michael-d-williams-dds-pa/1e8b7294-a8a3-4541-82f4-64a9f5abc834

> FDA 483 for Michael D. Williams, D.D.S., P.A. on March 31, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael D. Williams, D.D.S., P.A.
- Inspection Date: 2022-03-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.globalkeysolutions.net/companies/michael-d-williams-dds-pa/eb30bee0-be79-467b-854a-100edf755d93

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6