FDA Inspection
Endologix IncEndologix Inc – FDA Inspection, Sep 25, 2014
Record Details
This FDA Inspection record concerns Endologix Inc, with an inspection on September 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Endologix Inc
- Inspection Date
- September 25, 2014
- Product Type
- Devices
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ID · 7e5f964a-4e08-417e-9f09-9f2e6ffd2b60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897738
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Endologix Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Endologix Inc
- FDA Inspection 986033 - 2016-08-18
- FDA Inspection 919698 - 2015-01-22
- FDA Inspection 782063 - 2012-05-04
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