FDA Inspection
Planmeca OyPlanmeca Oy – FDA Inspection, Nov 1, 2018
Record Details
This FDA Inspection record concerns Planmeca Oy, with an inspection on November 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3a6245e-38c7-481d-a263-71050a5a09e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070539
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Planmeca Oy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 16, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Planmeca Oy
- FDA Inspection 839376 - 2013-06-06
- FDA Inspection 617543 - 2009-09-16
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