Company
IcelandOssur H / F, Reykjavik, Iceland – FDA Inspections
Inspection records and compliance data for Ossur H / F in Reykjavik. 3 FDA inspections on record, 1 Form 483, last inspected November 15, 2018.
Company Profile
This profile covers Ossur H / F based in Reykjavik, Iceland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 23, 2014. Last inspected November 15, 2018.
Most cited issue areas
- Documentation of software validation1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2018 | Not classified | Medical Devices & Rad Health | 1106568 |
| August 17, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1022620 |
| January 23, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 866481 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ossur H / F
FEI Number
3003764610
Address
Grjothals 5, Reykjavik, Iceland
Country
Iceland
ID: b2721cde-7eba-4dc9-93b8-4b4c9a633f6f