FDA Inspection 823495 — UltraRad Corporation
The FDA completed an inspection of UltraRad Corporation on March 26, 2013 in Voorhees, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Voorhees, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3837 | 21 CFR 820.25(b) | Training records |