Company
United StatesMedtronic Xomed, Inc., Mystic, CT – FDA Inspections
Inspection records and compliance data for Medtronic Xomed, Inc. in Mystic, Connecticut. 4 FDA inspections on record, last inspected July 20, 2017.
Company Profile
This profile covers Medtronic Xomed, Inc. based in Mystic, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2010. Last inspected July 20, 2017.
Most cited issue areas
- Acceptance status1 inspection
- Documentation of validated process performance1 inspection
- Initial Submission of Baseline Report1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2017 | Not classified | Medical Devices & Rad Health | 1037122 |
| September 21, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 945195 |
| July 3, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 790810 |
| August 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678198 |
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 Xomed, Inc.
FEI Number
1000159144
Address
950 Flanders Rd, Mystic, Connecticut 06355, United States
Country
United States
ID: 6ffa5499-3e31-4fa6-ae06-fd73e422a277