FDA Inspection 842544 — CMR Naviscan Corporation
The FDA completed an inspection of CMR Naviscan Corporation on Jul 31, 2013 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |