FDA Inspection
Cerner Enviza LLCCerner Enviza LLC – FDA Inspection, Jun 21, 2017
Record Details
This FDA Inspection record concerns Cerner Enviza LLC, with an inspection on June 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9a1e8d3f-218d-4c65-b441-865c86f2508f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015239
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Cerner Enviza LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2018 | Not classified | Kansas City District Office | |
| May 30, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 1, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cerner Enviza LLC
- FDA Inspection 1122961 - 2018-09-18
- FDA Inspection 880256 - 2014-05-30
- FDA Inspection 667664 - 2010-06-01
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