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

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.