FDA Inspection
Palodex Group OyPalodex Group Oy – FDA Inspection, Sep 4, 2015
Record Details
This FDA Inspection record concerns Palodex Group Oy, with an inspection on September 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Palodex Group Oy
- Inspection Date
- September 4, 2015
- Product Type
- Devices
View Company Profile
ID · cc1dd147-70e6-4309-98dd-e77eedd70fdf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944319
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Palodex Group Oy
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2019 | Not classified | Office of Inspections and Investigations | |
| January 31, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 5, 2012 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 30, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 30, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Palodex Group Oy
- FDA Inspection 1156767 - 2019-08-16
- FDA Inspection 1082204 - 2019-01-31
- FDA Inspection 800785 - 2012-09-05
- FDA Inspection 669980 - 2009-09-30
- FDA Inspection 669974 - 2009-09-30
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