Order Express
⚠️ Moderate Risk
FEI: 3004131309 • Colcentro • 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
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2003 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 84RX DEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Order Express's FDA import refusal history?
Order Express (FEI: 3004131309) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 12/15/2003.
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. Order Express's FEI number is 3004131309.
What types of violations has Order Express received?
Order Express 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 Order Express come from?
All FDA import refusal data for Order Express 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.