FDA Inspection 1021969 — UltraRad Corporation
The FDA completed an inspection of UltraRad Corporation on August 17, 2017 in Voorhees, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Voorhees, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |