FDA Inspection 1063035 — GN Hearing A/S
The FDA completed an inspection of GN Hearing A/S on Aug 23, 2018 in Ballerup. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ballerup (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3696 | 21 CFR 820.100(b) | Documentation |