Pfizer Canada Inc. - Kirkland, QC Administrative Site
🚨 Critical Risk
FEI: 3001203985 • Kirkland, Quebec • CANADA
FEI Number
3001203985
Location
Kirkland, Quebec
Country
CANADAAddress
17300 Rte Transcanadienne, , Kirkland, Quebec, Canada
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2025 | 64GCA16CONJUGATED ESTROGENS (ESTROGEN) | Division of Southeast Imports (DSEI) | |
| 2/11/2025 | 63OCY11RIMEGEPANT SULFATE (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2025 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 5/28/2024 | 64LCA45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2024 | 64GAA16CONJUGATED ESTROGENS (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2024 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 62ICY31METHOTREXATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/29/2022 | 60CIK04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/2/2022 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/6/2022 | 60CCY04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2022 | 64LCA44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2021 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/10/2020 | 63FDI15DEXRAZOXANE (CARDIOTONIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 62GAA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2019 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2019 | 64LCY44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2019 | 66BBJ99STIMULANT N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/28/2019 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2019 | 60LBY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2017 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/17/2016 | 66FDB02SULFAPYRIDINE (SUPPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 62GDB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 56CAA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 56FBK30POLYMYXIN B SULFATE (PEPTIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2011 | 60LDA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 1/4/2011 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2010 | 60LDB99ANALGESIC, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/25/2010 | 61QDA05TOLTERODINE TARTRATE (ANTI-DIURETIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/19/2010 | 62OCC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/4/2010 | 61JCP08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/4/2010 | 66SCN36VERAPAMIL (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2010 | 60LBB05ASPIRIN (ANALGESIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/31/2010 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2010 | 61JAB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/19/2010 | 61MCE23PHENYTOIN (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/27/2010 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/28/2008 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/21/2007 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/16/2007 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 7/5/2006 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/1/2006 | 62CBB64ACCURETIC (ANTI-HYPERTENSIVE) | Florida District Office (FLA-DO) | |
| 10/25/2005 | 62OCP04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/26/2005 | 61NDB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/14/2005 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 3/4/2005 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/30/2004 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2004 | 61NDH78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2004 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/20/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/26/2003 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2003 | 61TCA11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/14/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/14/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/21/2003 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Detroit District Office (DET-DO) | |
| 2/10/2003 | 61JCY99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/17/2002 | 63ECA99CARDIAC DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/3/2002 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/1/2002 | 60LCC83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/1/2002 | 60LCC83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/11/2002 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | Detroit District Office (DET-DO) | |
| 9/11/2002 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | Detroit District Office (DET-DO) | |
| 9/9/2002 | 65PDB02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/5/2002 | 65PCC02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/26/2002 | 64UDA99INHIBITOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/5/2002 | 61XCC45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/1/2002 | 60LCC83CELECOXIB (ANALGESIC) | Cincinnati District Office (CIN-DO) | |
| 4/1/2002 | 60LCC83CELECOXIB (ANALGESIC) | Cincinnati District Office (CIN-DO) | |
| 4/1/2002 | 62ODC04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | Cincinnati District Office (CIN-DO) | |
| 4/1/2002 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Cincinnati District Office (CIN-DO) | |
| 4/1/2002 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Cincinnati District Office (CIN-DO) | |
| 1/2/2002 | 56YBS99ANTIBIOTIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pfizer Canada Inc. - Kirkland, QC Administrative Site's FDA import refusal history?
Pfizer Canada Inc. - Kirkland, QC Administrative Site (FEI: 3001203985) has 79 FDA import refusal record(s) in our database, spanning from 1/2/2002 to 12/17/2025.
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. Pfizer Canada Inc. - Kirkland, QC Administrative Site's FEI number is 3001203985.
What types of violations has Pfizer Canada Inc. - Kirkland, QC Administrative Site received?
Pfizer Canada Inc. - Kirkland, QC Administrative Site 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 Pfizer Canada Inc. - Kirkland, QC Administrative Site come from?
All FDA import refusal data for Pfizer Canada Inc. - Kirkland, QC Administrative Site 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.