589973
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Solon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |