FDA Inspection
MEDTRONIC IRELANDMEDTRONIC IRELAND – FDA Inspection, Feb 12, 2016
Record Details
This FDA Inspection record concerns MEDTRONIC IRELAND, with an inspection on February 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MEDTRONIC IRELAND
- Inspection Date
- February 12, 2016
- Product Type
- Devices
View Company Profile
ID · e6fb5200-e5cb-4ffd-b557-cab0ce7c95b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969068
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MEDTRONIC IRELAND
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2016 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| November 20, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 15, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MEDTRONIC IRELAND
- FDA Inspection 992239 - 2016-10-27
- FDA Inspection 904708 - 2014-11-20
- FDA Inspection 880677 - 2014-05-15
- FDA Inspection 823591 - 2013-03-22
- FDA Inspection 789749 - 2012-06-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.