AMAZON EU SARL, UK BRANCH
⚠️ High Risk
FEI: 3014306516 • London • UNITED KINGDOM
FEI Number
3014306516
Location
London
Country
UNITED KINGDOMAddress
1 Principal Place, Worship Street, London, , United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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 |
|---|---|---|---|
| 5/22/2025 | 83PGHHSV-1 AND HSV-2 CNS NUCLEIC-ACID BASED PANEL | Division of Southeast Imports (DSEI) | |
| 1/26/2021 | 62VDY18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/28/2020 | 62VJJ18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/16/2020 | 66BBY44NICOTINE DELIVERY SYSTEM | Division of Northern Border Imports (DNBI) | |
| 9/4/2020 | 62VAO18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/18/2020 | 62VAY18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AMAZON EU SARL, UK BRANCH's FDA import refusal history?
AMAZON EU SARL, UK BRANCH (FEI: 3014306516) has 6 FDA import refusal record(s) in our database, spanning from 8/18/2020 to 5/22/2025.
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. AMAZON EU SARL, UK BRANCH's FEI number is 3014306516.
What types of violations has AMAZON EU SARL, UK BRANCH received?
AMAZON EU SARL, UK BRANCH has been cited for 4 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.