Novartis Pharmaceuticals Canada Inc.
⚠️ High Risk
FEI: 3002260858 • Dorval, Quebec • CANADA
FEI Number
3002260858
Location
Dorval, Quebec
Country
CANADAAddress
385 Bouchard Blvd, , Dorval, Quebec, 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).
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 |
|---|---|---|---|
| 3/4/2025 | 58MDY25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MDY25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58ACK04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 61ECE99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 58ACK04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2024 | 58ADL04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2024 | 58ADY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 58ACK04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2023 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2023 | 62NAP10SECUKINUMAB (ANTI-PSORIATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2023 | 61PCL99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2022 | 64TCA99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2020 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 9/14/2020 | 56YBK99ANTIBIOTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/12/2019 | 64GCD07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 62TCY99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2019 | 61ECB99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2016 | 64GDD07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/8/2016 | 66BRA19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/17/2015 | 62GCA89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/8/2012 | 65VCC13CLOZAPINE (SEDATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/17/2012 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/23/2011 | 61NCE44NORTRIPTYLINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2010 | 54YCF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 62OAA44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/17/2008 | 62OCH12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/17/2008 | 62OCP44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/13/2007 | 64RDY99HORMONE N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/5/2006 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/25/2005 | 62OCP37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/26/2005 | 62ODB44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/7/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/8/2004 | 62TCA04OCTREOTIDE ACETATE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2003 | 65RCA14POTASSIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novartis Pharmaceuticals Canada Inc.'s FDA import refusal history?
Novartis Pharmaceuticals Canada Inc. (FEI: 3002260858) has 52 FDA import refusal record(s) in our database, spanning from 8/26/2003 to 3/4/2025.
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. Novartis Pharmaceuticals Canada Inc.'s FEI number is 3002260858.
What types of violations has Novartis Pharmaceuticals Canada Inc. received?
Novartis Pharmaceuticals 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 Novartis Pharmaceuticals Canada Inc. come from?
All FDA import refusal data for Novartis Pharmaceuticals 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.