# FDA 483 - CFS Dental, Inc - September 08, 2022

Source: https://www.keypedia.com/records/483/cfs-dental-inc/5beae3a2-dc9f-4795-a72d-5a43d19e6c55

> FDA 483 for CFS Dental, Inc on September 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CFS Dental, Inc
- Inspection Date: 2022-09-08
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: CFS Dental, Inc. in Hialeah, FL, a medical device manufacturer, was cited for failing to adequately establish and implement design change procedures. Specifically, the firm did not validate current melt times for its CFS Flexible thermoplastic dental resin device across all cartridge sizes. This indicates a breakdown in quality system controls related to product design and manufacturing parameters.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/cfs-dental-inc/55bcebe0-4b8a-4c94-b83b-b64fad7f5403

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