FDA Inspection 610037 — Cardiovascular Imaging Technologies, LLC.
The FDA completed an inspection of Cardiovascular Imaging Technologies, LLC. on Sep 8, 2009 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3381 | 21 CFR 820.198(e)(7) | Corrective action taken |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |