ICU Medical Costa Rica Ltd. — FDA Facility Profile
ICU Medical Costa Rica Ltd. is an FDA-registered facility (FEI 3002999813) located in La Aurora de Heredia, CR. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Feb 23, 2015: No Action Indicated (NAI)
- Inspections on record
- 2 (1 OAI, 1 NAI)
- Last OAI inspection
- Apr 19, 2012
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 27, 2012
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 23, 2015 | No Action Indicated (NAI) | No citations listed |
| Apr 19, 2012 | Official Action Indicated (OAI) | Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Lack of or inadequate procedures (21 CFR 820.100(a)) Evaluation of suppliers, contractors, etc., requirements (21 CFR 820.50(a)) |
Facility details
- Company
- ICU Medical Costa Rica Ltd.
- Location
- La Aurora de Heredia (CR)
- Source
- device