ASTRAZENECA UK LTD
⚠️ High Risk
FEI: 3013088018 • Cambridge, CAM • UNITED KINGDOM
FEI Number
3013088018
Location
Cambridge, CAM
Country
UNITED KINGDOMAddress
1 Francis Crick Avenue, , Cambridge, CAM, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 64GCL99ESTROGEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2022 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2022 | 61PCY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2018 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ASTRAZENECA UK LTD's FDA import refusal history?
ASTRAZENECA UK LTD (FEI: 3013088018) has 5 FDA import refusal record(s) in our database, spanning from 9/7/2018 to 5/29/2025.
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. ASTRAZENECA UK LTD's FEI number is 3013088018.
What types of violations has ASTRAZENECA UK LTD received?
ASTRAZENECA UK LTD has been cited for 1 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.