Delpharm Montreal Inc.
⚠️ Moderate Risk
FEI: 3002808099 • Pointe-Claire, Quebec • CANADA
FEI Number
3002808099
Location
Pointe-Claire, Quebec
Country
CANADAAddress
3535 Rte Transcanadienne, , Pointe-Claire, Quebec, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2021 | 61WIJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2012 | 61XAA99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/19/2012 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2011 | 61XBB15DEXBROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/14/2010 | 62VIA12RIBAVIRIN (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/1/2008 | 55EG99ADDITIVES IN PLASTICS, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/4/2008 | 61JIA15EZETIMIBE | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/17/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/29/2006 | 65JCA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 65JCA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/29/2004 | 62FAB53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2004 | 66FDA99SUPPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/13/2004 | 61EIP08LORATADINE (ANTI-ASTHMATIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 63BRQ03AZANATOR MALEATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/16/2003 | 65JDY37PROMETRIUM (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Delpharm Montreal Inc.'s FDA import refusal history?
Delpharm Montreal Inc. (FEI: 3002808099) has 15 FDA import refusal record(s) in our database, spanning from 9/16/2003 to 8/13/2021.
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. Delpharm Montreal Inc.'s FEI number is 3002808099.
What types of violations has Delpharm Montreal Inc. received?
Delpharm Montreal 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 Delpharm Montreal Inc. come from?
All FDA import refusal data for Delpharm Montreal 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.