FDA Inspection
CMR Naviscan CorporationCMR Naviscan Corporation – FDA Inspection, Jul 18, 2024
Record Details
This FDA Inspection record concerns CMR Naviscan Corporation, with an inspection on July 18, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 88ba73c5-561a-4e3f-b20e-98aca71e0b6a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1244076
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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Other FDA inspections of CMR Naviscan Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2013 | 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 944056 - 2015-09-17
- FDA Inspection 842544 - 2013-07-31
- FDA Inspection 607627 - 2009-08-27
- FDA Inspection 609252 - 2009-02-11
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