FDA Inspection
ICU Medical, Inc.ICU Medical, Inc. – FDA Inspection, Feb 7, 2013
Record Details
This FDA Inspection record concerns ICU Medical, Inc., with an inspection on February 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ICU Medical, Inc.
- Inspection Date
- February 7, 2013
- Product Type
- Devices
View Company Profile
ID · bca86fc0-79ef-4d94-9848-7beb295e4742
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 818394
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 803.52(b)(2)Death
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.40Lack of procedures, or not maintained
- 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(a)Design control - no procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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 |
| May 27, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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 925591 - 2015-05-27
- FDA Inspection 923940 - 2015-04-21
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