Arabian European B
⚠️ Moderate Risk
FEI: 3004058534 • Dubai • UNITED ARAB EMIRATES
FEI Number
3004058534
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
Dubai Pearl Bldg, , Dubai, , United Arab Emirates
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2004 | 34CYY99CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) | New Orleans District Office (NOL-DO) | |
| 7/27/2003 | 86MWLLENS, CONTACT (RIGID GAS PERMEABLE) - EXTENDED WEAR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Arabian European B's FDA import refusal history?
Arabian European B (FEI: 3004058534) has 2 FDA import refusal record(s) in our database, spanning from 7/27/2003 to 12/13/2004.
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. Arabian European B's FEI number is 3004058534.
What types of violations has Arabian European B received?
Arabian European B has been cited for 4 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 Arabian European B come from?
All FDA import refusal data for Arabian European B 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.