FDA Inspection
MEDTRONIC IRELANDMEDTRONIC IRELAND – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns MEDTRONIC IRELAND, with an inspection on October 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Kimberly Lewandowski-Walker (Issuing Officer)
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ID · e2cb75b8-7bab-4f74-b76f-d1438c51fe76
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992239
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of MEDTRONIC IRELAND
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 969068 - 2016-02-12
- FDA Inspection 904708 - 2014-11-20
- FDA Inspection 880677 - 2014-05-15
- FDA Inspection 823591 - 2013-03-22
- FDA Inspection 789749 - 2012-06-28
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