DMX IMAGING, LLC – FDA Inspection, Jun 7, 2012

Record Details

This FDA Inspection record concerns DMX IMAGING, LLC, with an inspection on June 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: DMX IMAGING, LLC
Inspection Date: June 7, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · ffe2ff98-51f9-4e5c-b5d7-5580f5bd63df

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 785658
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.80(e)Documentation
21 CFR 1020.30(d)(1)Report of assembly submitted within 15 days
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 806.20(b)(4)Justification for not reporting
21 CFR 1002.10(j)Warning signs, labels, instructions
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.25(a)Personnel
21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures

Showing 10 of 16 citations.

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Other FDA inspections of DMX IMAGING, LLC

Date	Classification	Office	Project area
December 4, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 5, 2015	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
June 20, 2013	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices