FDA Inspection 581483 — Advanced Imaging Research Inc, DBA Sree Medical Systems
The FDA completed an inspection of Advanced Imaging Research Inc, DBA Sree Medical Systems on June 2, 2009 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |