FDA Inspection
Medtronic Vascular, Inc.Medtronic Vascular, Inc. – FDA Inspection, Oct 15, 2021
Record Details
This FDA Inspection record concerns Medtronic Vascular, Inc., with an inspection on October 15, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Vascular, Inc.
- Inspection Date
- October 15, 2021
- Product Type
- Devices
View Company Profile
ID · b38c58b9-8f74-4825-a235-d99c9aa3afdb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155023
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Vascular, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Vascular, Inc.
- FDA Inspection 973289 - 2016-06-02
- FDA Inspection 829995 - 2013-02-27
- FDA Inspection 710946 - 2011-02-24
- FDA Inspection 546657 - 2008-10-30
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.