Company
SwedenOticon Medical Ab, Askim, Sweden – FDA Inspections
Inspection records and compliance data for Oticon Medical Ab in Askim. 2 FDA inspections on record, 1 Form 483, last inspected September 25, 2019.
Company Profile
This profile covers Oticon Medical Ab based in Askim, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 20, 2014. Last inspected September 25, 2019.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Supplier oversight1 inspection
- Training - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2019 | Not classified | Medical Devices & Rad Health | 1128856 |
| February 20, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 867732 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Oticon Medical Ab
FEI Number
3007367732
Address
Datavagen 37b, Askim, Sweden
Country
Sweden
ID: b6891058-2856-4e8c-99f0-e8db738e7932