774266
Andersen Products, Inc. — FEI 1000112091
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 29, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Haw River, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |