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Amazon.Es

✅ Low Risk

FEI: 3010520899 • San Fernando De Henares, Madrid • SPAIN

FEI

FEI Number

3010520899

📍

Location

San Fernando De Henares, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Amazon, Avenida Astronomia 2, San Fernando De Henares, Madrid, Spain

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
7/30/2015
Latest Refusal
7/30/2015
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
7/30/2015
79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
341REGISTERED
473LABELING
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Amazon.Es's FDA import refusal history?

Amazon.Es (FEI: 3010520899) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2015 to 7/30/2015.

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.Es's FEI number is 3010520899.

What types of violations has Amazon.Es received?

Amazon.Es 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 Amazon.Es come from?

All FDA import refusal data for Amazon.Es 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.