Merck Frosst Canada, Ltd.
⚠️ High Risk
FEI: 3002807565 • Kirkland, Quebec • CANADA
FEI Number
3002807565
Location
Kirkland, Quebec
Country
CANADAAddress
16711 Rte Transcanadienne, , Kirkland, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2025 | 61PCY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2025 | 61PCB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2025 | 61PCB68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 62GCA86ALLOPURINOL SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2022 | 61EIY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2021 | 62BDB99ANTI-HYPERLIPIDEMIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2012 | 61ECB09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2011 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/2/2008 | 61TBC99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/26/2008 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/13/2008 | 64UIY06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/11/2008 | 64UCB06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2007 | 64UIB06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/26/2006 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/12/2005 | 61LBA01ACENOCOUMAROL (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/15/2005 | 64UCC06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/16/2004 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/16/2004 | 64UDB06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 61EDA99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/29/2004 | 64UCB06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/1/2002 | 60LCC83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/22/2002 | 64UDA99INHIBITOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/1/2002 | 60LCC83CELECOXIB (ANALGESIC) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Merck Frosst Canada, Ltd.'s FDA import refusal history?
Merck Frosst Canada, Ltd. (FEI: 3002807565) has 25 FDA import refusal record(s) in our database, spanning from 4/1/2002 to 12/11/2025.
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. Merck Frosst Canada, Ltd.'s FEI number is 3002807565.
What types of violations has Merck Frosst Canada, Ltd. received?
Merck Frosst Canada, Ltd. has been cited for 2 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 Merck Frosst Canada, Ltd. come from?
All FDA import refusal data for Merck Frosst Canada, Ltd. 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.