822959
BURTON MEDICAL — FEI 3009542956
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Addison, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2338 | 21 CFR 820.22 | Quality audit - audit report review |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |