Company
DenmarkGN Hearing A/S, Ballerup, Denmark – FDA Inspections
Inspection records and compliance data for GN Hearing A/S in Ballerup. 2 FDA inspections on record, 1 Form 483, last inspected August 23, 2018.
Company Profile
This profile covers GN Hearing A/S based in Ballerup, Denmark.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected November 29, 2012. Last inspected August 23, 2018.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1063035 |
| November 29, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 816564 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GN Hearing A/S
FEI Number
3005650109
Address
Lautrupbjerg 7, Ballerup, Denmark
Country
Denmark
ID: ff0646b0-aa10-43cd-afd6-9803aaa2c31e