1179631
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |