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# QS Violations at Denterprise International
- URL: https://www.fdaweb.com/qs-violations-at-denterprise-international/
- Published: 2019-10-15T12:00:00.000Z
- Updated: 2026-09-15T01:56:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145247

A 5/1-5/6 FDA inspection at Denterprise International, Ormond Beach, FL, found Quality System Regulation and other violations in the firm’s work as specification developer, manufacturer of the FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. A 10/9 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/denterprise-international-inc-586932-10092019?ref=fdaweb.com) says specific violations, that were all repeat deficiencies, were: 

- although not appearing on the FDA-483, failing to establish procedures for design control;
- failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirement;
- failing to include information in complaint records;
- failing to adequately establish procedures for quality audits;
- failing to adequately establish procedures for acceptance activities; and
- failing to establish and maintain procedures for device history records.

The inspection also identified a radiological health significant deviation for failing to report immediately to the CDRH director an accidental radiation occurrence reported to or otherwise known by the company involving a product introduced or intended to be introduced into commerce by the company.

Denterprise was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence with documentation of each step and a timetable for implementation.