554275
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 16, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fremont, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |