563170
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 5, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Schaffhausen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2330 | 21 CFR 820.22 | Quality audit corrective action, reaudits {see also 820.100} |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4061 | 21 CFR 820.20(b)(3)(ii) | Management representative's reports |
| 4189 | 21 CFR 820.198(a) | General |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 537 | 21 CFR 820.70(a) | Production processes |