FDA Inspection
Endologix IncEndologix Inc – FDA Inspection, Aug 18, 2016
Record Details
This FDA Inspection record concerns Endologix Inc, with an inspection on August 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Endologix Inc
- Inspection Date
- August 18, 2016
- Product Type
- Devices
View Company Profile
ID · 45771134-fc6f-4907-897c-9a52caee029c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986033
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Endologix Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 4, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Endologix Inc
- FDA Inspection 919698 - 2015-01-22
- FDA Inspection 897738 - 2014-09-25
- FDA Inspection 782063 - 2012-05-04
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