843883
MAST Biosurgery USA Inc — FEI 3004661493
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 8, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |