XZeal Technologies, Inc. – FDA Warning Letter, Sep 18, 2014

On February 20, 2015, the FDA issued a Warning Letter to XZeal Technologies, Inc. following an inspection from September 17-18, 2014, which identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803) for their XZeal Dental X-Ray Unit Z70. The device was deemed adulterated and misbranded.

Key violations include: 1. **Design Validation (21 CFR 820.30(g))**: Failure to establish and maintain procedures for design validation, including testing under defined operating conditions with actual or simulated use, and inadequate software validation for embedded software, including risk assessment. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a))**: Procedures lacked appropriate statistical methodology for detecting recurring problems and did not ensure verification/validation of CAPA effectiveness. 3. **Complaint Handling (21 CFR 820.198(a))**: Failure to document oral complaints, evaluate complaints for MDR reportability, and ensure procedures contained required elements for processing complaints. 4. **Environmental Control (21 CFR 820.70(c))**: Inadequate procedures to control environmental conditions, specifically Electrostatic