702452
Merz North America, Inc. — FEI 3003407669
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 23, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Franksville, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |