DynaRad X-Ray, LLC – FDA Inspection, Oct 8, 2010

Record Details

This FDA Inspection record concerns DynaRad X-Ray, LLC, with an inspection on October 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: DynaRad X-Ray, LLC
Inspection Date: October 8, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · e3d7dbe8-39ef-44ba-922e-24d7a3daa23b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 685196
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.20(d)Quality plan
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance 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 820.198(a)Lack of or inadequate complaint procedures

Showing 10 of 17 citations.

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Other FDA inspections of DynaRad X-Ray, LLC

Date	Classification	Office	Project area
September 24, 2012	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
October 8, 2010	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 30, 2010	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act