Company
United StatesDatex-Ohmeda, Inc., Madison, WI – FDA Inspections
Inspection records and compliance data for Datex-Ohmeda, Inc. in Madison, Wisconsin. 6 FDA inspections on record, 1 Form 483, last inspected November 17, 2023.
Company Profile
This profile covers Datex-Ohmeda, Inc. based in Madison, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected January 28, 2011. Last inspected November 17, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1223234 |
| March 1, 2023 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1200471 |
| May 4, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1169942 |
| August 3, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1064872 |
| June 12, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 930736 |
| January 28, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 712376 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Datex-Ohmeda, Inc.
FEI Number
2112667
Address
3030 Ohmeda Dr, Madison, Wisconsin 53718, United States
Country
United States
ID: c517cfc9-b6f5-47f3-af19-68a1c6b54d00