Company
United StatesEndologix Inc, Irvine, CA – FDA Inspections
Inspection records and compliance data for Endologix Inc in Irvine, California. 4 FDA inspections on record, last inspected August 18, 2016.
Company Profile
This profile covers Endologix Inc based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 4, 2012. Last inspected August 18, 2016.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Identification procedures, Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 18, 2016 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 986033 |
| January 22, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 919698 |
| September 25, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 897738 |
| May 4, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 782063 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Endologix Inc
FEI Number
1000125107
Address
11 Studebaker, Irvine, California 92618, United States
Country
United States
ID: 757f4084-dec9-496b-9366-89a490a441bf