# FDA WARNING_LETTER - CFS Dental, Inc - December 04, 2012

Source: https://www.keypedia.com/records/warning_letter/cfs-dental-inc/43490b2b-cf0b-4bea-8f28-40018379d2fc

> FDA WARNING_LETTER for CFS Dental, Inc on December 04, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CFS Dental, Inc
- Inspection Date: 2012-12-04
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On January 16, 2013, the FDA issued a Warning Letter to CFS Dental, Inc. following an inspection from December 3-4, 2012. The inspection revealed that the firm's CFS Flexible Cartridge device was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Key violations include:
1.  **Design Control (21 CFR 820.30):** Failure to establish and maintain procedures for design control, including verification, validation, design transfer, and control of design changes. Specific issues included lack of documentation for design verification/validation, failure to ensure correct translation of design into production specifications, and undocumented changes to material specifications and labeling (e.g., color pigment change, removal of heating warnings/instructions, lot number, and net weight from labeling).
2.  **Process Validation (21 CFR 820.75(a)):** Failure to validate the vacuum sealer process for the final packaging, which is critical for protecting the device from humidity intrusion and maintaining functionality.
3.

## Related Documents

- [483 - 2023-10-31](https://www.keypedia.com/records/483/cfs-dental-inc/357ef282-e0e8-4334-8f40-0f2f97a46f0e)

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9