Denterprise International, Inc. – FDA Warning Letter, May 6, 2019

The FDA issued a Warning Letter to Denterprise International, Inc. following an inspection from May 1-6, 2019, which identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their FlashRay dental X-ray sensor and MobileX, Model T-100, dental X-ray system. These devices were deemed adulterated.

Key violations include: 1. **Lack of Design Control Procedures (21 CFR 820.30(a))**: The firm failed to establish procedures for design inputs, outputs, review, verification, validation, transfer, and change for the FlashRay sensor. A Design History File (DHF) was also not maintained for the FlashRay, a repeat deficiency from previous communications. 2. **Inadequate Purchasing Controls (21 CFR 820.50(b))**: The Supplier Qualification Plan was insufficient, and the firm failed to evaluate the manufacturer of the MobileX system, a repeat deficiency. 3. **Incomplete Complaint Records (21 CFR 820.198(e))**: Complaint records lacked sufficient detail, including investigation dates and results, and failed to report accidental radiation exposures (AROs) to the FDA, a repeat deficiency. 4. **Insufficient Quality Audit Procedures (21 CFR 820.22)**: Internal quality audits were not performed at