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Smart City

⚠️ Moderate Risk

FEI: 3006149157 • Grand Duche • LUXEMBOURG

FEI

FEI Number

3006149157

📍

Location

Grand Duche

🇱🇺

Country

LUXEMBOURG
🏢

Address

Sa Prieure 6, , Grand Duche, , Luxembourg

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
4/26/2007
Latest Refusal
4/13/2007
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4821×

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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
4/26/2007
61NCY82GALANTAMINE HYDROBROMIDE (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
4/13/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Smart City's FDA import refusal history?

Smart City (FEI: 3006149157) has 2 FDA import refusal record(s) in our database, spanning from 4/13/2007 to 4/26/2007.

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. Smart City's FEI number is 3006149157.

What types of violations has Smart City received?

Smart City has been cited for 2 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 Smart City come from?

All FDA import refusal data for Smart City 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.