FDA Inspection
ICU Medical Costa Rica Ltd.ICU Medical Costa Rica Ltd. – FDA Inspection, Apr 19, 2012
Record Details
This FDA Inspection record concerns ICU Medical Costa Rica Ltd., with an inspection on April 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ICU Medical Costa Rica Ltd.
- Inspection Date
- April 19, 2012
- Product Type
- Devices
View Company Profile
ID · 8604c3b6-bfd3-4c84-81b9-aadc392e0203
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 780800
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance 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 Costa Rica Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2018 | Not classified | Office of Inspections and Investigations | |
| March 24, 2017 | Not classified | Office of Inspections and Investigations | |
| March 9, 2017 | Not classified | Office of Inspections and Investigations | |
| February 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ICU Medical Costa Rica Ltd.
- FDA Inspection 1077660 - 2018-04-05
- FDA Inspection 1014073 - 2017-03-24
- FDA Inspection 1010913 - 2017-03-09
- FDA Inspection 919381 - 2015-02-23
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