Denterprise International, Inc. – FDA Inspection, Aug 19, 2021

Record Details

This FDA Inspection record concerns Denterprise International, Inc., with an inspection on August 19, 2021, issued by the Center for Devices and Radiological Health, covering devices.

Company: Denterprise International, Inc.
Inspection Date: August 19, 2021
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f5bac0b9-404a-4a81-b3d8-13eeeeebfc43

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1149181
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.20(c)Management review - Lack of or inadequate 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 803.17(a)(1)Lack of System for Event Evaluations
21 CFR 1002.10Failure to submit, distinct marking

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Other FDA inspections of Denterprise International, Inc.

Date	Classification	Office	Project area
May 6, 2019	OAI	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