SANDOZ CANADA INC
⚠️ High Risk
FEI: 3012334740 • Boucherville, Quebec • CANADA
FEI Number
3012334740
Location
Boucherville, Quebec
Country
CANADAAddress
110 De Lauzon St, , Boucherville, 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).
708LISTING
It has been determined the drug is not included in a list required by Section 510(j).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 64GCY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2025 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2024 | 62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2024 | 61QCE99ANTI-DIURETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2024 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/24/2023 | 62ODB18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 3872708LISTING | Division of Southeast Imports (DSEI) |
| 11/16/2023 | 61PDB70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2023 | 62ODB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 61PCS99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2022 | 62ODY19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 12/3/2022 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2022 | 62JDA09LEVODOPA (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2021 | 60TDP14NALOXONE HCL (ANTAGONIST) | Division of West Coast Imports (DWCI) | |
| 8/19/2021 | 62CDA68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2021 | 63ADA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2021 | 54AFB15VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/10/2020 | 64LDI20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2019 | 66MCA95TEMAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2019 | 62OCA32FELODIPINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SANDOZ CANADA INC's FDA import refusal history?
SANDOZ CANADA INC (FEI: 3012334740) has 22 FDA import refusal record(s) in our database, spanning from 11/26/2019 to 11/10/2025.
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. SANDOZ CANADA INC's FEI number is 3012334740.
What types of violations has SANDOZ CANADA INC received?
SANDOZ 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 SANDOZ CANADA INC come from?
All FDA import refusal data for SANDOZ 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.