FDA Inspection
ICU Medical, Inc.ICU Medical, Inc. – FDA Inspection, Apr 4, 2019
Record Details
This FDA Inspection record concerns ICU Medical, Inc., with an inspection on April 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 9d6a866b-5ba6-4ea5-a6e1-6892dee29786
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085121
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ICU Medical, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 15, 2018 | Not classified | Denver District Office | |
| March 17, 2017 | Not classified | Denver District Office | |
| March 8, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 11, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ICU Medical, Inc.
- FDA Inspection 1229208 - 2024-09-26
- FDA Inspection 1082931 - 2018-03-15
- FDA Inspection 1013934 - 2017-03-17
- FDA Inspection 981035 - 2016-03-08
- FDA Inspection 956414 - 2015-12-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.