ICU Medical de Mexico, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003807466 • Ensenada, Baja California • MEXICO
FEI Number
3003807466
Location
Ensenada, Baja California
Country
MEXICOAddress
Avenida Cuarzo 250, Col. Canon Buenavista, Ensenada, Ensenada, Baja California, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/23/2019 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/6/2016 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/19/2012 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 10/5/2012 | 80FMGSTOPCOCK, I.V. SET | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is ICU Medical de Mexico, S.A. de C.V.'s FDA import refusal history?
ICU Medical de Mexico, S.A. de C.V. (FEI: 3003807466) has 31 FDA import refusal record(s) in our database, spanning from 10/5/2012 to 5/23/2019.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. ICU Medical de Mexico, S.A. de C.V.'s FEI number is 3003807466.
What types of violations has ICU Medical de Mexico, S.A. de C.V. received?
ICU Medical de Mexico, S.A. de C.V. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about ICU Medical de Mexico, S.A. de C.V. come from?
All FDA import refusal data for ICU Medical de Mexico, S.A. de C.V. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.