947464
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 19, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boulder, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |