FDA Inspection
ICU Medical, Inc.ICU Medical, Inc. – FDA Inspection, Nov 30, 2012
Record Details
This FDA Inspection record concerns ICU Medical, Inc., with an inspection on November 30, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ICU Medical, Inc.
- Inspection Date
- November 30, 2012
- Product Type
- Devices
View Company Profile
ID · 9ddb86f7-0374-46ca-8308-71268505a5a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809344
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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 |
| April 4, 2019 | VAI | 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 |
Other documents for ICU Medical, Inc.
- FDA Inspection 1229208 - 2024-09-26
- FDA Inspection 1085121 - 2019-04-04
- FDA Inspection 1082931 - 2018-03-15
- FDA Inspection 1013934 - 2017-03-17
- FDA Inspection 981035 - 2016-03-08
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.