FDA Inspection 607627 — CMR Naviscan Corporation
The FDA completed an inspection of CMR Naviscan Corporation on Aug 27, 2009 in Carlsbad, CA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 27, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3675 | 21 CFR 820.30(f) | Design verification - unresolved discrepancies |