FDA Inspection
Medart A /SMedart A /S – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns Medart A /S, with an inspection on May 31, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · f8ee9721-a5ca-43ec-819a-805b393d4521
Inspection Facts
- Inspection number
- 1053704
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Medart A /S
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 1, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medart A /S
- FDA Inspection 944716 - 2015-09-24
- FDA Inspection 849997 - 2013-09-13
- FDA Inspection 789470 - 2012-06-01
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