Company
FinlandPlanmeca Oy, Helsinki, Finland – FDA Inspections
Inspection records and compliance data for Planmeca Oy in Helsinki. 3 FDA inspections on record, 1 Form 483, last inspected November 01, 2018.
Company Profile
This profile covers Planmeca Oy based in Helsinki, Finland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 16, 2009. Last inspected November 1, 2018.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- DHR content1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 1, 2018 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1070539 |
| June 6, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 839376 |
| September 16, 2009 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 617543 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Planmeca Oy
FEI Number
1000207287
Address
Asentajankatu 6, Helsinki, Finland
Country
Finland
ID: 3e74b133-96fc-41ff-8824-cadd6eaf19a7