596171
Admedes GmbH — FEI 3003956144
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 25, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pforzheim (Germany)
Citations
| ID | CFR | Description |
|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |