# FDA 483 - CFS Dental, Inc - October 31, 2023

Source: https://www.keypedia.com/records/483/cfs-dental-inc/357ef282-e0e8-4334-8f40-0f2f97a46f0e

> FDA 483 for CFS Dental, Inc on October 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CFS Dental, Inc
- Inspection Date: 2023-10-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: CFS Dental, Inc. in Hialeah, FL, received a Form FDA 483 following an inspection from October 30-31, 2023. The inspection revealed one observation related to the firm's failure to evaluate potential suppliers and contractors. Specifically, the firm lacked required quality agreements with its resin supplier, indicating a deficiency in their quality system regarding supplier management.

## Related Documents

- [WARNING_LETTER - 2012-12-04](https://www.keypedia.com/records/warning_letter/cfs-dental-inc/43490b2b-cf0b-4bea-8f28-40018379d2fc)

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/cfs-dental-inc/6bbb759d-0fe4-4786-a688-35a15788dfd5

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