SEI Medical S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003565456 • Juarez, Chihuahua • MEXICO
FEI Number
3003565456
Location
Juarez, Chihuahua
Country
MEXICOAddress
Roberto Fierro 6420 & Francisco Sarabia, Parque Ind. Aeropuerto, Juarez, Chihuahua, 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 |
|---|---|---|---|
| 4/13/2015 | 78GCABILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRAST INJECTION | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SEI Medical S.A. de C.V.'s FDA import refusal history?
SEI Medical S.A. de C.V. (FEI: 3003565456) has 1 FDA import refusal record(s) in our database, spanning from 4/13/2015 to 4/13/2015.
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. SEI Medical S.A. de C.V.'s FEI number is 3003565456.
What types of violations has SEI Medical S.A. de C.V. received?
SEI Medical 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 SEI Medical S.A. de C.V. come from?
All FDA import refusal data for SEI Medical 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.