FDA Inspection
De Novo SoftwareDe Novo Software – FDA Inspection, Jul 9, 2014
Record Details
This FDA Inspection record concerns De Novo Software, with an inspection on July 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- De Novo Software
- Inspection Date
- July 9, 2014
- Product Type
- Devices
View Company Profile
ID · b9ab7a3e-c5f3-4469-b54f-55b5c964d3ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886592
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(a)Design control - no procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of De Novo Software
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for De Novo Software
- FDA Inspection 966276 - 2016-03-23
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