1022703
COSMED Nordic ApS — FEI 1000334329
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 24, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Odense S (Denmark)
Citations
| ID | CFR | Description |
|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |