Sanofi Pasteur Limited
⚠️ High Risk
FEI: 3002888623 • North York, Ontario • CANADA
FEI Number
3002888623
Location
North York, Ontario
Country
CANADAAddress
1755 Steeles Ave W, , North York, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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).
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 |
|---|---|---|---|
| 12/19/2025 | 58ACP02DUPILUMAB | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/4/2020 | 56YDK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/20/2012 | 57EH10TUBERCULIN, PURIFIED PROTEIN DERIVATIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/11/2012 | 57HJ32BCG VACCINE | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2008 | 57IY05DIPTHERIA, TETANUS AND ACELLULAR PERTUSSIS (DTAP) VACCINE | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 7/22/2008 | 57IY05DIPTHERIA, TETANUS AND ACELLULAR PERTUSSIS (DTAP) VACCINE | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 12/14/2004 | 57CY02INFLUENZA VIRUS VACCINE | Cincinnati District Office (CIN-DO) | |
| 12/6/2004 | 57CY02INFLUENZA VIRUS VACCINE | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sanofi Pasteur Limited's FDA import refusal history?
Sanofi Pasteur Limited (FEI: 3002888623) has 9 FDA import refusal record(s) in our database, spanning from 12/6/2004 to 12/19/2025.
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. Sanofi Pasteur Limited's FEI number is 3002888623.
What types of violations has Sanofi Pasteur Limited received?
Sanofi Pasteur Limited 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 Sanofi Pasteur Limited come from?
All FDA import refusal data for Sanofi Pasteur Limited 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.