667159
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nixa, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |