Company
United StatesPublic company, NASDAQ: ICUIICU Medical Inc (NASDAQ: ICUI), Austin, TX – FDA Inspections
Inspection records and compliance data for ICU Medical Inc in Austin, Texas. 7 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 20, 2024. Publicly traded as NASDAQ: ICUI.
Company Profile
This profile covers ICU Medical Inc based in Austin, Texas, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected December 11, 2009. Last inspected September 20, 2024.
Most cited issue areas
- Procedures for sterile drug products4 inspections
- Procedures to be written and followed3 inspections
- Scientifically sound laboratory controls3 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2024 | Not classified | Human Drugs · Drug Quality Assurance | 1230651 |
| June 28, 2024 | NAI | Biologics · Blood and Blood Products | 1243793 |
| March 10, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1009809 |
| May 23, 2014 | VAI | Human Drugs · Drug Quality Assurance | 880543 |
| August 24, 2012 | VAI | Human Drugs · Drug Quality Assurance | 796073 |
| April 27, 2011 | OAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 723658 |
| December 11, 2009 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 633621 |
FDA documents
People (4)
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
1628454
Address
3900 Howard Ln, Austin, Texas 78728, United States
Country
United States
ID: 007b8fa8-5781-4269-b963-3f0a6fbe5362