Company
IrelandMEDTRONIC IRELAND, Galway, Ireland – FDA Inspections
Inspection records and compliance data for MEDTRONIC IRELAND in Galway. 8 FDA inspections on record (1 OAI), 1 Form 483, last inspected October 27, 2016.
Company Profile
This profile covers MEDTRONIC IRELAND based in Galway, Ireland.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 3
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected December 10, 2009. Last inspected October 27, 2016.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Deviations from laboratory control requirements1 inspection
- Equipment design and installation1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 27, 2016 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 992239 |
| February 12, 2016 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 969068 |
| November 20, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 904708 |
| May 15, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 880677 |
| March 22, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 823591 |
| June 28, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 789749 |
| May 26, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 732055 |
| December 10, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 635483 |
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 IRELAND
FEI Number
3002806434
Address
Parkmore Business Park West, Galway, Ireland
Country
Ireland
ID: eb59435f-e3d7-493a-9b22-52e3575f021d