FDA Inspection 1001546 — B-K Medical A/S
The FDA completed an inspection of B-K Medical A/S on Jan 26, 2017 in Herlev. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Herlev (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3837 | 21 CFR 820.25(b) | Training records |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |