FDA Inspection
Endologix, Inc.Endologix, Inc. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Endologix, Inc., with an inspection on May 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a7159e94-6fbe-407c-9a82-c7edfbabd7e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091013
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Endologix, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2025 | Not classified | San Francisco District Office | |
| March 5, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 30, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 31, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 1, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Endologix, Inc.
- FDA Inspection 1281848 - 2025-08-14
- FDA Inspection 917051 - 2015-03-05
- FDA Inspection 853638 - 2013-10-30
- FDA Inspection 797087 - 2012-08-31
- FDA Inspection 742920 - 2011-09-01
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