Company
United StatesMedtronic Vascular, Inc., Santa Rosa, CA – FDA Inspections
Inspection records and compliance data for Medtronic Vascular, Inc. in Santa Rosa, California. 10 FDA inspections on record, last inspected July 11, 2019.
Company Profile
This profile covers Medtronic Vascular, Inc. based in Santa Rosa, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 2
- NAI
- 8
- Form 483s
- 0
- Warning letters
- 0
First inspected October 9, 2008. Last inspected July 11, 2019.
Most cited issue areas
- No investigator agreement1 inspection
- Sponsor records of investigator agreements inadequate1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1096966 |
| August 31, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1030899 |
| November 7, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 901694 |
| November 14, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 855281 |
| February 22, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 819376 |
| November 27, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 810454 |
| January 13, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 762885 |
| November 10, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 701775 |
| November 20, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 637813 |
| October 9, 2008 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 546030 |
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
Medtronic Vascular, Inc.
FEI Number
3001452571
Address
3576 Unocal Pl, Santa Rosa, California 95403, United States
Country
United States
ID: 3f4db393-29fc-4eec-91ae-845a424fe407