FDA Inspection
Medtronic Xomed, Inc.Medtronic Xomed, Inc. – FDA Inspection, Jul 3, 2012
Record Details
This FDA Inspection record concerns Medtronic Xomed, Inc., with an inspection on July 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Xomed, Inc.
- Inspection Date
- July 3, 2012
- Product Type
- Devices
View Company Profile
ID · 6ddab755-c24d-41d0-85a9-fa0214a5d39d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 790810
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.55(a)Initial Submission of Baseline Report
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.86Acceptance status
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Xomed, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | Not classified | New England District Office | |
| September 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic Xomed, Inc.
- FDA Inspection 1037122 - 2017-07-20
- FDA Inspection 945195 - 2015-09-21
- FDA Inspection 678198 - 2010-08-05
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