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Smiths Detection Emea

⚠️ Moderate Risk

FEI: 3007545798 • Wiesbaden, Hesse • GERMANY

FEI

FEI Number

3007545798

📍

Location

Wiesbaden, Hesse

🇩🇪

Country

GERMANY
🏢

Address

Im Herzen 4, , Wiesbaden, Hesse, Germany

Moderate Risk

FDA Import Risk Assessment

46.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/21/2025
Latest Refusal
8/21/2025
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
92.0×20%
Frequency
10.0×10%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
8/21/2025
94RCGSECURITY X-RAY (INCLUDES BAGGAGE X-RAY), CABINET X-RAY SYSTEMS, NON-MEDICAL
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Smiths Detection Emea's FDA import refusal history?

Smiths Detection Emea (FEI: 3007545798) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2025 to 8/21/2025.

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. Smiths Detection Emea's FEI number is 3007545798.

What types of violations has Smiths Detection Emea received?

Smiths Detection Emea 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 Smiths Detection Emea come from?

All FDA import refusal data for Smiths Detection Emea 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.