881940
Cellpack Ag — FEI 3009153862
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Villmergen (Switzerland)
Citations
| ID | CFR | Description |
|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |