AMAZON EU SARL, UK BRANCH
⚠️ Moderate Risk
FEI: 3014363500 • London • UNITED KINGDOM
FEI Number
3014363500
Location
London
Country
UNITED KINGDOMAddress
Principal Place, Amazon Way; 1 Worship Street, London, , United Kingdom
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 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).
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.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2019 | 95RAALASER PRODUCTS (PRE-STANDARD) | Division of Northern Border Imports (DNBI) | |
| 12/13/2019 | 95RAALASER PRODUCTS (PRE-STANDARD) | Division of Northern Border Imports (DNBI) | |
| 3/28/2019 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is AMAZON EU SARL, UK BRANCH's FDA import refusal history?
AMAZON EU SARL, UK BRANCH (FEI: 3014363500) has 3 FDA import refusal record(s) in our database, spanning from 3/28/2019 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, UK BRANCH's FEI number is 3014363500.
What types of violations has AMAZON EU SARL, UK BRANCH received?
AMAZON EU SARL, UK BRANCH has been cited for 6 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, UK BRANCH come from?
All FDA import refusal data for AMAZON EU SARL, UK BRANCH 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.