770816
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 13, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Buffalo Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5598 | 21 CFR 1020.30(e) | Word "model" or "type" permanent and legible |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |