FDA Inspection
Cerenovus, Inc.Cerenovus, Inc. – FDA Inspection, Nov 5, 2013
Record Details
This FDA Inspection record concerns Cerenovus, Inc., with an inspection on November 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cerenovus, Inc.
- Inspection Date
- November 5, 2013
- Product Type
- Devices
View Company Profile
ID · eb65ab13-013c-4287-8e54-a7390ddb40d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855739
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Cerenovus, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 17, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cerenovus, Inc.
- FDA Inspection 985968 - 2016-09-21
- FDA Inspection 746797 - 2011-09-27
- FDA Inspection 712819 - 2011-03-04
- FDA Inspection 673154 - 2010-06-17
- FDA Inspection 628600 - 2009-11-17
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