Denterprise International, Inc. – FDA Inspection, May 6, 2019

Record Details

This FDA Inspection record concerns Denterprise International, Inc., with an inspection on May 6, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Denterprise International, Inc.
Inspection Date: May 6, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Joshua J. Silvestri

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ID · 96e00864-6d1c-4e4d-a6c5-13a14c845ea6

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1090180
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued
Enforcement: Warning Letter

FDA Citations

21 CFR 1010.2(b)Certification label or tag
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.198(e)Records of complaint investigation
21 CFR 1020.30(j)Mandatory warning on control panel
21 CFR 803.17(a)(1)Lack of System for Event Evaluations
21 CFR 1002.20(a)Failure to report
21 CFR 1002.10Failure to submit, distinct marking

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Other FDA inspections of Denterprise International, Inc.

Date	Classification	Office	Project area
August 19, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 12, 2018	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
July 29, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices