AstraZeneca Canada Inc.
⚠️ High Risk
FEI: 3002806268 • Mississauga, Ontario • CANADA
FEI Number
3002806268
Location
Mississauga, Ontario
Country
CANADAAddress
1004 Middlegate Rd, , Mississauga, Ontario, Canada
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2025 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2025 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2025 | 64UCY99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2025 | 61EDQ04BUDESONIDE (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 12/5/2025 | 61PCY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2025 | 62IDA99ANTI-NEOPLASTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/22/2025 | 61EDY04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 61ECY99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/2/2024 | 61PDY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2024 | 63BDQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2023 | 62KCB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2021 | 62TDB06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2021 | 61JDB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2019 | 61PCA70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/9/2018 | 61EDR04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2016 | 60QDK40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2012 | 64RCP17ANASTROZOLE (HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2012 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/15/2011 | 61EDQ04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/5/2007 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 66SCP48ISOSORBIDE MONONITRATE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/30/2005 | 60XBC17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/22/2003 | 60LCY99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/17/2003 | 80MEDSTERILANT, MEDICAL DEVICES | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/17/2003 | 80BRZSET, BLOOD TRANSFUSION | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/5/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/11/2002 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/15/2002 | 61ECE04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/14/2001 | 61ECE04BUDESONIDE (ANTI-ASTHMATIC) | Detroit District Office (DET-DO) | |
| 10/31/2001 | 64BAB37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is AstraZeneca Canada Inc.'s FDA import refusal history?
AstraZeneca Canada Inc. (FEI: 3002806268) has 34 FDA import refusal record(s) in our database, spanning from 10/31/2001 to 12/18/2025.
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 Canada Inc.'s FEI number is 3002806268.
What types of violations has AstraZeneca Canada Inc. received?
AstraZeneca Canada Inc. has been cited for 3 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 Canada Inc. come from?
All FDA import refusal data for AstraZeneca Canada Inc. 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.