FDA Inspection
Inogen, IncInogen, Inc – FDA Inspection, Aug 23, 2017
Record Details
This FDA Inspection record concerns Inogen, Inc, with an inspection on August 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c7df525a-429c-4b0a-b8eb-4ac905b8abd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022883
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(c)Investigation of device failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Inogen, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2018 | Not classified | Dallas District Office | |
| June 26, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Inogen, Inc
- FDA Inspection 1127095 - 2018-09-27
- FDA Inspection 837168 - 2013-06-26
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