884938
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 25, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |