FDA Inspection 1072346 — RadLogics, Inc.
The FDA completed an inspection of RadLogics, Inc. on Nov 20, 2018 in Piedmont, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 20, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Piedmont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2 | 21 CFR 11 | Electronic signatures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |