AstraZeneca UK Ltd.
⚠️ High Risk
FEI: 3002850317 • Macclesfield, Cheshire • UNITED KINGDOM
FEI Number
3002850317
Location
Macclesfield, Cheshire
Country
UNITED KINGDOMAddress
Charter Way, Silk Road Business Park, Macclesfield, Cheshire, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 61PCY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61PCY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/27/2025 | 62IAY81GOSERELIN ACETATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/9/2021 | 62ZCL37OLAPARIB (ANTI-NEOPLASTIC - PART II) | Division of Northeast Imports (DNEI) | |
| 12/5/2019 | 66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 63BCY99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/29/2018 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 60QCK84PROPOFOL (ANESTHETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/9/2017 | 61PIS99ANTI-DIABETIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/13/2015 | 62CAC65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | New Orleans District Office (NOL-DO) | |
| 6/19/2012 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/23/2007 | 62CCP65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/29/2005 | 63FQY99CARDIOTONIC N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 4/28/2005 | 61NDA99ANTI-DEPRESSANT N.E.C. | 473LABELING | Florida District Office (FLA-DO) |
| 1/30/2004 | 61JDB99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AstraZeneca UK Ltd.'s FDA import refusal history?
AstraZeneca UK Ltd. (FEI: 3002850317) has 16 FDA import refusal record(s) in our database, spanning from 1/30/2004 to 9/3/2025.
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 3002850317.
What types of violations has AstraZeneca UK Ltd. received?
AstraZeneca UK Ltd. has been cited for 7 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.