FDA Inspection 546257 — U-systems Inc
The FDA completed an inspection of U-systems Inc on October 30, 2008 in Sunnyvale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sunnyvale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |