FDA Inspection
ICU Medical, Inc.ICU Medical, Inc. – FDA Inspection, May 27, 2015
Record Details
This FDA Inspection record concerns ICU Medical, Inc., with an inspection on May 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ICU Medical, Inc.
- Inspection Date
- May 27, 2015
- Product Type
- Devices
View Company Profile
ID · e80a10af-76a7-4144-a353-1fb31be1e3c9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 925591
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.30(h)Incorrect translation to production specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ICU Medical, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 17, 2017 | Not classified | Chicago District Office | |
| July 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 28, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ICU Medical, Inc.
- FDA Inspection 1250066 - 2024-09-09
- FDA Inspection 1018654 - 2017-03-17
- FDA Inspection 984996 - 2016-07-14
- FDA Inspection 923940 - 2015-04-21
- FDA Inspection 881787 - 2014-05-28
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