Sun Pharma Canada Inc.
⚠️ High Risk
FEI: 3002808384 • Brampton, Ontario • CANADA
FEI Number
3002808384
Location
Brampton, Ontario
Country
CANADAAddress
130 East Dr, , Brampton, 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
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 |
|---|---|---|---|
| 8/29/2025 | 62GAL41IBUPROFEN (ANTI-INFLAMMATORY) | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 8/29/2025 | 56YBJ99ANTIBIOTIC N.E.C. | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 5/22/2025 | 61LCY99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2024 | 61NDJ24DOXEPIN HCL (ANTI-DEPRESSANT) | Division of Northern Border Imports (DNBI) | |
| 7/8/2024 | 61NDJ24DOXEPIN HCL (ANTI-DEPRESSANT) | Division of Northern Border Imports (DNBI) | |
| 5/13/2024 | 64LCO04BETAMETHASONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2024 | 61EAL08LORATADINE (ANTI-ASTHMATIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/20/2024 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | Division of Southeast Imports (DSEI) | |
| 1/25/2023 | 61EAL08LORATADINE (ANTI-ASTHMATIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/25/2023 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 12/22/2021 | 65RCJ29TRETINOIN (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 8/19/2021 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2021 | 61JCB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2019 | 61LCA13WARFARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2018 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/31/2018 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/7/2018 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/7/2018 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/20/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/18/2008 | 61WCJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/15/2004 | 56FAJ01BACITRACIN PEPTIDE (PEPTIDES) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/9/2003 | 64LAJ37HYDROCORTISONE (GLUCOCORTICOID) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sun Pharma Canada Inc.'s FDA import refusal history?
Sun Pharma Canada Inc. (FEI: 3002808384) has 23 FDA import refusal record(s) in our database, spanning from 12/9/2003 to 8/29/2025.
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. Sun Pharma Canada Inc.'s FEI number is 3002808384.
What types of violations has Sun Pharma Canada Inc. received?
Sun Pharma 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 Sun Pharma Canada Inc. come from?
All FDA import refusal data for Sun Pharma 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.