Astrazeneca
⚠️ Moderate Risk
FEI: 3003363346 • Macclesfield, Cheshire • UNITED KINGDOM
FEI Number
3003363346
Location
Macclesfield, Cheshire
Country
UNITED KINGDOMAddress
Mereside, Alderley Park, Macclesfield, Cheshire, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2016 | 60QBO67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2008 | 66NCB03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/10/2004 | 62LBY52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Astrazeneca's FDA import refusal history?
Astrazeneca (FEI: 3003363346) has 3 FDA import refusal record(s) in our database, spanning from 6/10/2004 to 5/3/2016.
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's FEI number is 3003363346.
What types of violations has Astrazeneca received?
Astrazeneca 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 come from?
All FDA import refusal data for Astrazeneca 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.