Groupe Parima Inc.
⚠️ High Risk
FEI: 3003773810 • Saint-Laurent, Quebec • CANADA
FEI Number
3003773810
Location
Saint-Laurent, Quebec
Country
CANADAAddress
4450 Cousens St, , Saint-Laurent, 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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2019 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 9/3/2019 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 9/3/2019 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 8/15/2017 | 61WQL47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 8/15/2017 | 61WQL47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 6/19/2017 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 6/19/2017 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 2/23/2017 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 2/23/2017 | 61WRL18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 4/5/2016 | 62FBK53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | Detroit District Office (DET-DO) | |
| 12/4/2014 | 61HDK45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 64XCL06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/31/2012 | 61HCL45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/2/2011 | 61GDJ45SULFACETAMIDE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 7/27/2011 | 64DCJ99EMOLLIENT, LUBRICANT, N.E.C. | New York District Office (NYK-DO) | |
| 7/27/2011 | 64DCJ99EMOLLIENT, LUBRICANT, N.E.C. | New York District Office (NYK-DO) | |
| 7/15/2011 | 64DCJ99EMOLLIENT, LUBRICANT, N.E.C. | New York District Office (NYK-DO) | |
| 7/15/2011 | 64XCJ03BENZOYL PEROXIDE (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 4/28/2011 | 61GDL45SULFACETAMIDE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 3/31/2011 | 62SDL99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 3/31/2011 | 62SBL99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 3/31/2011 | 64EDJ13TRYPSIN CRYSTALLIZED (ENZYME) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/7/2010 | 60QDJ40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 9/23/2002 | 64DCJ99EMOLLIENT, LUBRICANT, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/4/2002 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/4/2002 | 60QDY40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/4/2002 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Groupe Parima Inc.'s FDA import refusal history?
Groupe Parima Inc. (FEI: 3003773810) has 33 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 9/3/2019.
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. Groupe Parima Inc.'s FEI number is 3003773810.
What types of violations has Groupe Parima Inc. received?
Groupe Parima Inc. has been cited for 4 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 Groupe Parima Inc. come from?
All FDA import refusal data for Groupe Parima 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.