Company
Costa RicaICU Medical Costa Rica Ltd., Heredia, Costa Rica – FDA Inspections
Inspection records and compliance data for ICU Medical Costa Rica Ltd. in Heredia. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 05, 2018.
Company Profile
This profile covers ICU Medical Costa Rica Ltd. based in Heredia, Costa Rica.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected April 19, 2012. Last inspected April 5, 2018.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 5, 2018 | Not classified | Medical Devices & Rad Health | 1077660 |
| March 24, 2017 | Not classified | Medical Devices & Rad Health | 1014073 |
| March 9, 2017 | Not classified | Medical Devices & Rad Health | 1010913 |
| February 23, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 919381 |
| April 19, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 780800 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ICU Medical Costa Rica Ltd.
FEI Number
3002999813
Address
La Aurora De Heredia,1 Km Noreste Del Centro Comercial, Real Cariari, ZONA FRANCA GLOBAL Park De Entrada 300, Heredia, Costa Rica
Country
Costa Rica
ID: 29dd87f0-decd-48fc-9d5d-bb60081dbbbb