Teva Canada Limited
🚨 Critical Risk
FEI: 3002807756 • Scarborough, Ontario • CANADA
FEI Number
3002807756
Location
Scarborough, Ontario
Country
CANADAAddress
30 Novopharm Crt, , Scarborough, Ontario, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2025 | 62CAY65LISINOPRIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 6/25/2025 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2025 | 56CCB27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2024 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2024 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2023 | 62IIY79FLUDARABINE PHOSPHATE (ANTI-NEOPLASTIC) | Division of Southeast Imports (DSEI) | |
| 5/26/2023 | 61JCA11GEMFIBROZIL (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2022 | 61JCB16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 6/30/2022 | 61NAH80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2022 | 63BCY02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2022 | 62KQY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 63OCA05RIZATRIPTAN BENZOATE (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 62ODA03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2020 | 66MDB86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2019 | 64LDY03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/9/2018 | 61NCE80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2017 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2016 | 66VDE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2016 | 56JCA20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/18/2016 | 62OCA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/30/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/2/2016 | 63ECL13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2014 | 61NCA73MIRTAZAPINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2012 | 61TCA31DOMPERIDONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 61MCA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/13/2012 | 63XIP99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/5/2012 | 61NDB80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 62GCA89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 62GCA89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2011 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/23/2011 | 66NCA03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/23/2011 | 61MCA35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2011 | 64SCA29ZOPICLONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/2/2009 | 61GCA84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/16/2007 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/26/2005 | 61HDB99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/11/2005 | 61VCA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 3/4/2005 | 66VDQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New York District Office (NYK-DO) |
| 3/3/2005 | 61VCA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2004 | 61VCA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2004 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/5/2004 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/5/2004 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/5/2004 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/2/2003 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2002 | 64BDB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/27/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/20/2002 | 63XIY99DIAGOSTIC AID (DRUGS) N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/12/2002 | 61NAY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/20/2001 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/14/2001 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/31/2001 | 66YAB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Teva Canada Limited's FDA import refusal history?
Teva Canada Limited (FEI: 3002807756) has 56 FDA import refusal record(s) in our database, spanning from 10/31/2001 to 12/10/2025.
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. Teva Canada Limited's FEI number is 3002807756.
What types of violations has Teva Canada Limited received?
Teva Canada Limited has been cited for 4 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 Teva Canada Limited come from?
All FDA import refusal data for Teva Canada 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.