Denterprise International, Inc. – FDA Inspection, Jul 29, 2016

Record Details

This FDA Inspection record concerns Denterprise International, Inc., with an inspection on July 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Denterprise International, Inc.
Inspection Date: July 29, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f324c72d-2ad9-4b29-8707-3a759e9a95d4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 982613
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 1010.3(a)ID label or tag
21 CFR 1010.2(a)Lack of certification of conformance
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

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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
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