1084183
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 28, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |