FDA Inspection
CMR Naviscan CorporationCMR Naviscan Corporation – FDA Inspection, Jul 31, 2013
Record Details
This FDA Inspection record concerns CMR Naviscan Corporation, with an inspection on July 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CMR Naviscan Corporation
- Inspection Date
- July 31, 2013
- Product Type
- Devices
View Company Profile
ID · f318b81d-aceb-4d46-b465-3a51ca20be6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842544
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CMR Naviscan Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CMR Naviscan Corporation
- FDA Inspection 1244076 - 2024-07-18
- FDA Inspection 944056 - 2015-09-17
- FDA Inspection 607627 - 2009-08-27
- FDA Inspection 609252 - 2009-02-11
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