FDA Inspection
Cerenovus IncCerenovus Inc – FDA Inspection, Mar 14, 2014
Record Details
This FDA Inspection record concerns Cerenovus Inc, with an inspection on March 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cerenovus Inc
- Inspection Date
- March 14, 2014
- Product Type
- Devices
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ID · b55fff30-4c5d-4eb7-93a5-43d99511406b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 870464
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Cerenovus Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2018 | Not classified | Florida District Office | |
| September 30, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 30, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Cerenovus Inc
- FDA Inspection 1109629 - 2018-10-26
- FDA Inspection 988070 - 2016-09-30
- FDA Inspection 706633 - 2010-12-30
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