704598
Rebuilder Medical, Inc. — FEI 3004987960
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charles Town, WV (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |