Company
United StatesTornier, Inc, Bloomington, MN – FDA Inspections
Inspection records and compliance data for Tornier, Inc in Bloomington, Minnesota. 7 FDA inspections on record, last inspected July 15, 2015.
Company Profile
This profile covers Tornier, Inc based in Bloomington, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected May 14, 2009. Last inspected July 15, 2015.
Most cited issue areas
- Change records, content1 inspection
- Documentation1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 15, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 938240 |
| March 26, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 872141 |
| January 31, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 817044 |
| November 3, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 754158 |
| December 11, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 633844 |
| November 17, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 630053 |
| May 14, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 586544 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Tornier, Inc
FEI Number
3000718467
Address
10801 Nesbitt Ave S, Bloomington, Minnesota 55437, United States
Country
United States
ID: 698aef20-20e8-446e-893f-990a9bd42213