Medart A /S – FDA Inspection, Jun 1, 2012

Record Details

This FDA Inspection record concerns Medart A /S, with an inspection on June 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Medart A /S
Inspection Date: June 1, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · c4d812c2-c81b-42d1-913c-75482b98c5bf

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 789470
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.30(b)Design plans - Lack of or inadequate
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(e)Design review - Lack of or inadequate procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
21 CFR 820.250(a)Statistical techniques - Lack of or inadequate 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 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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Other FDA inspections of Medart A /S

Date	Classification	Office	Project area
May 31, 2018	Not classified	Office of Inspections and Investigations	Radiation Control and Health Safety Act
September 24, 2015	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
September 13, 2013	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices