# FDA WARNING_LETTER - Denterprise International, Inc. - May 06, 2019

Source: https://www.keypedia.com/records/warning_letter/denterprise-international-inc/0f4d6b7f-28a8-42f1-a6b9-45fbaf1624e0

> FDA WARNING_LETTER for Denterprise International, Inc. on May 06, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Denterprise International, Inc.
- Inspection Date: 2019-05-06
- Product Type: Devices
- Office Name: Division of Medical Device and Radiological Health Operations Central
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/blake-bevill/7ed0dcde-28a7-452b-870d-6e085580abde)

Company: https://www.keypedia.com/companies/denterprise-international-inc/ce1ada61-2b45-4025-9110-1c3eee71b376

Office: https://www.keypedia.com/offices/division-of-medical-device-and-radiological-health-operations-central/b44fc5d5-1aa5-406a-b241-fc5a5958072d