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AMAZON EU SARL

⚠️ Moderate Risk

FEI: 3014931864 • Luxembourg • POLAND

FEI

FEI Number

3014931864

📍

Location

Luxembourg

🇵🇱

Country

POLAND
🏢

Address

38 Avenue John F. Kennedy, , Luxembourg, , Poland

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
12/23/2019
Latest Refusal
12/13/2019
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2783×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

473×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

4763×

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
12/23/2019
95RAALASER PRODUCTS (PRE-STANDARD)
278NO TAG
47NON STD
476NO REGISTR
Division of Northern Border Imports (DNBI)
12/23/2019
95RAALASER PRODUCTS (PRE-STANDARD)
278NO TAG
47NON STD
476NO REGISTR
Division of Northern Border Imports (DNBI)
12/13/2019
95RAALASER PRODUCTS (PRE-STANDARD)
278NO TAG
47NON STD
476NO REGISTR
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is AMAZON EU SARL's FDA import refusal history?

AMAZON EU SARL (FEI: 3014931864) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2019 to 12/23/2019.

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. AMAZON EU SARL's FEI number is 3014931864.

What types of violations has AMAZON EU SARL received?

AMAZON EU SARL 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 AMAZON EU SARL come from?

All FDA import refusal data for AMAZON EU SARL 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.