Archtek Dental, LLC – FDA Inspection, Jun 2, 2011

Record Details

This FDA Inspection record concerns Archtek Dental, LLC, with an inspection on June 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Archtek Dental, LLC
Inspection Date: June 2, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 4834a708-911b-4d78-b317-ba270a32774e

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 728178
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(a)Complaints
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 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Showing 10 of 15 citations.

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Other FDA inspections of Archtek Dental, LLC

Date	Classification	Office	Project area
October 25, 2018	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 26, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices