Company
FinlandPalodex Group Oy, Tuusula, Finland – FDA Inspections
Inspection records and compliance data for Palodex Group Oy in Tuusula. 6 FDA inspections on record, 1 Form 483, last inspected August 16, 2019.
Company Profile
This profile covers Palodex Group Oy based in Tuusula, Finland.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2009. Last inspected August 16, 2019.
Most cited issue areas
- DHR content1 inspection
- Documentation1 inspection
- Training - Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2019 | Not classified | Medical Devices & Rad Health | 1156767 |
| January 31, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1082204 |
| September 4, 2015 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 944319 |
| September 5, 2012 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 800785 |
| September 30, 2009 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 669980 |
| September 30, 2009 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 669974 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Palodex Group Oy
FEI Number
3005383085
Address
Nahkelantie 160, Tuusula, Finland
Country
Finland
ID: a133e74f-4bd4-48d4-b630-978673ba524b