Astra Zeneca Canada Inc.
⚠️ Moderate Risk
FEI: 3002829763 • Mississauga, Ontario • CANADA
FEI Number
3002829763
Location
Mississauga, Ontario
Country
CANADAAddress
1004 Middlegate Rd Suite 5000, , Mississauga, Ontario, Canada
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2022 | 60QDK40LIDOCAINE HCL (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 5/5/2020 | 61LCA99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2015 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/27/2012 | 62OCA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/14/2011 | 62TAY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/3/2011 | 60QBO86EMLA (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/21/2010 | 61ECY04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/13/2009 | 66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/17/2006 | 61EBQ99ANTI-ASTHMATIC, N.E.C. | Detroit District Office (DET-DO) | |
| 3/4/2005 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/4/2005 | 61EDQ04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2004 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2004 | 62TDB02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Astra Zeneca Canada Inc.'s FDA import refusal history?
Astra Zeneca Canada Inc. (FEI: 3002829763) has 13 FDA import refusal record(s) in our database, spanning from 1/6/2004 to 6/15/2022.
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. Astra Zeneca Canada Inc.'s FEI number is 3002829763.
What types of violations has Astra Zeneca Canada Inc. received?
Astra Zeneca Canada Inc. has been cited for 5 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 Astra Zeneca Canada Inc. come from?
All FDA import refusal data for Astra Zeneca 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.