FDA Inspection 839422 — Codan Medical Aps.
The FDA completed an inspection of Codan Medical Aps. on June 20, 2013 in Rodby. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rodby (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |