FDA Inspection 659908 — UltraRad Corporation
The FDA completed an inspection of UltraRad Corporation on May 10, 2010 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
- May 10, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Voorhees, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |