Company
United StatesPublic company, NASDAQ: ICUIICU Medical, Inc. (NASDAQ: ICUI), Salt Lake City, UT – FDA Inspections
Inspection records and compliance data for ICU Medical, Inc. in Salt Lake City, Utah. 9 FDA inspections on record, 1 Form 483, last inspected September 26, 2024. Publicly traded as NASDAQ: ICUI.
Company Profile
This profile covers ICU Medical, Inc. based in Salt Lake City, Utah, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 22, 2010. Last inspected September 26, 2024.
Most cited issue areas
- Individual Report of Malfunction2 inspections
- Documentation1 inspection
- Documentation - review in response to changes or deviations1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1229208 |
| April 4, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1085121 |
| March 15, 2018 | Not classified | Medical Devices & Rad Health | 1082931 |
| March 17, 2017 | Not classified | Medical Devices & Rad Health | 1013934 |
| March 8, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 981035 |
| December 11, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 956414 |
| March 19, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 823230 |
| November 30, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 809344 |
| April 22, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 662390 |
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
ICU Medical, Inc.
Stock ticker
ICUI
Exchange
NASDAQ
Share price
$177.30
Market cap
$4.4B
Price as of
November 13, 2026
FEI Number
1713468
Address
4455 S Atherton Dr, Salt Lake City, Utah 84123, United States
Country
United States
ID: a284b8f1-a8bd-454b-ad2b-86e9098ab372