FDA Inspection
ICU Medical, Inc.ICU Medical, Inc. – FDA Inspection, Mar 19, 2013
Record Details
This FDA Inspection record concerns ICU Medical, Inc., with an inspection on March 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ICU Medical, Inc.
- Inspection Date
- March 19, 2013
- Product Type
- Devices
View Company Profile
ID · 8a961bd5-2f04-4e10-ae74-75bff9a635aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823230
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
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
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