FDA Inspection
CVRx, Inc.CVRx, Inc. – FDA Inspection, Nov 18, 2009
Record Details
This FDA Inspection record concerns CVRx, Inc., with an inspection on November 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CVRx, Inc.
- Inspection Date
- November 18, 2009
- Product Type
- Devices
View Company Profile
ID · e7cdcce1-ae3f-4315-8943-5e0f30d39d2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628243
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(2)Sponsor notification of IRB approval withdrawal
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CVRx, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2018 | Not classified | Minneapolis District Office | |
| July 16, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 31, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CVRx, Inc.
- FDA Inspection 1088890 - 2018-01-12
- FDA Inspection 935008 - 2015-07-16
- FDA Inspection 785234 - 2012-05-31
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