743827
Advantageous MD Llc — FEI 3007510735
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 12, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Virginia Beach, VA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |