AstraZeneca UK Ltd
⚠️ Moderate Risk
FEI: 3003589503 • Luton • UNITED KINGDOM
FEI Number
3003589503
Location
Luton
Country
UNITED KINGDOMAddress
Horizon Place, 600 Capability Green, Luton, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2012 | 60QCK07LIDOCAINE | New Orleans District Office (NOL-DO) | |
| 3/25/2011 | 60WCB18NICLOSAMIDE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/4/2007 | 66NCA03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/3/2006 | 63EAC13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/20/2005 | 66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/4/2005 | 63BBY32FORMOTEROL FUMARATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AstraZeneca UK Ltd's FDA import refusal history?
AstraZeneca UK Ltd (FEI: 3003589503) has 6 FDA import refusal record(s) in our database, spanning from 5/4/2005 to 3/14/2012.
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. AstraZeneca UK Ltd's FEI number is 3003589503.
What types of violations has AstraZeneca UK Ltd received?
AstraZeneca UK Ltd 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 AstraZeneca UK Ltd come from?
All FDA import refusal data for AstraZeneca UK Ltd 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.