658446
RS Medical — FEI 1000117825
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |