C I Importex
⚠️ Moderate Risk
FEI: 3008262962 • Medellin, Antioquia • COLOMBIA
FEI Number
3008262962
Location
Medellin, Antioquia
Country
COLOMBIAAddress
Carrera 80a 32ee 72, , Medellin, Antioquia, Colombia
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2012 | 64ABR20TRICLOSAN (DISINFECTANT) | Florida District Office (FLA-DO) | |
| 12/20/2011 | 33ACT12MIXED/ASSORTED HARD CANDIES W/NUT,NUT PRODS,SEEDS W/O COCONUT W/O CHOCOLATE | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/5/2011 | 34KFN04CHOCOLATE BARS | 473LABELING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is C I Importex's FDA import refusal history?
C I Importex (FEI: 3008262962) has 3 FDA import refusal record(s) in our database, spanning from 10/5/2011 to 6/5/2012.
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. C I Importex's FEI number is 3008262962.
What types of violations has C I Importex received?
C I Importex has been cited for 3 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 C I Importex come from?
All FDA import refusal data for C I Importex 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.