Delpharm Boucherville Canada, Inc.
⚠️ High Risk
FEI: 3000280957 • Boucherville, Quebec • CANADA
FEI Number
3000280957
Location
Boucherville, Quebec
Country
CANADAAddress
145 Jules-Leger 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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
708LISTING
It has been determined the drug is not included in a list required by Section 510(j).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2023 | 62TDC07PANTOPRAZOLE SODIUM | 3872708LISTING | Division of Southeast Imports (DSEI) |
| 6/29/2021 | 61LCY08HEPARIN SODIUM (ANTI-COAGULANT) | Division of Southeast Imports (DSEI) | |
| 7/9/2018 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2018 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2016 | 62ICK32METHOTREXATE SODIUM (ANTI-NEOPLASTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/28/2016 | 62TCC07PANTOPRAZOLE SODIUM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2015 | 54ADK02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/7/2012 | 64LDK20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2012 | 62ODA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/28/2009 | 54AFP05VITAMIN B12 (CYANOCOBALAMIN) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 6/9/2009 | 61NIB05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2008 | 61GCY06NEOMYCIN PALMITATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/5/2004 | 60NCP16TESTOSTERONE ENANTHATE (ANDROGEN) | San Francisco District Office (SAN-DO) | |
| 11/22/2002 | 61KCY16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/9/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/9/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/9/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/6/2001 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/6/2001 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Delpharm Boucherville Canada, Inc.'s FDA import refusal history?
Delpharm Boucherville Canada, Inc. (FEI: 3000280957) has 20 FDA import refusal record(s) in our database, spanning from 11/6/2001 to 11/24/2023.
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 Boucherville Canada, Inc.'s FEI number is 3000280957.
What types of violations has Delpharm Boucherville Canada, Inc. received?
Delpharm Boucherville Canada, Inc. has been cited for 6 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 Boucherville Canada, Inc. come from?
All FDA import refusal data for Delpharm Boucherville 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.