Company
United StatesMedtronic Xomed, Inc., Jacksonville, FL – FDA Inspections
Inspection records and compliance data for Medtronic Xomed, Inc. in Jacksonville, Florida. 5 FDA inspections on record, 1 Form 483, last inspected June 17, 2024.
Company Profile
This profile covers Medtronic Xomed, Inc. based in Jacksonville, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 19, 2008. Last inspected June 17, 2024.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Investigation of device failures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 17, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1240536 |
| October 29, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1156931 |
| July 27, 2017 | Not classified | Medical Devices & Rad Health | 1041671 |
| June 6, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 786597 |
| December 19, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 554176 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medtronic Xomed, Inc.
FEI Number
1045254
Address
6743 Southpoint Dr N, Jacksonville, Florida 32216, United States
Country
United States
ID: 1309a87b-9fb3-4260-ba3a-8cb515b17fc4