Pharma Exp
⚠️ High Risk
FEI: 3003206702 • Montreal, QC • CANADA
FEI
FEI Number
3003206702
📍
Location
Montreal, QC
🇨🇦
Country
CANADA🏢
Address
5480 Victoria, , Montreal, QC, Canada
High Risk
FDA Import Risk Assessment
62.4
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
112
Total Refusals
3
Unique Violations
10/17/2002
Latest Refusal
10/13/2001
Earliest Refusal
Score Breakdown
Violation Severity
73.9×40%
Refusal Volume
76.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
11584×
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
7524×
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).
1794×
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 |
|---|---|---|---|
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61WCA46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA75NEFAZODONE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA75NEFAZODONE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NAA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NAA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA73MIRTAZAPINE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 64TCE08TACROLIMUS (IMMUNOSUPPRESSIVE) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62TCF02LANSOPRAZOLE (ANTI-SECRETORY) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62TCF02LANSOPRAZOLE (ANTI-SECRETORY) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61MCA99ANTI-CONVULSANT, N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61MCA99ANTI-CONVULSANT, N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCE10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 60LCE83CELECOXIB (ANALGESIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 60LCE83CELECOXIB (ANALGESIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 56OCA02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61PCA99ANTI-DIABETIC N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61PCA99ANTI-DIABETIC N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62GDC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61PCA99ANTI-DIABETIC N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 63ACA07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 63ACA07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62VCA42VALACYCLOVIR HCL (ANTI-VIRAL) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61FCA61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61WCA46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA75NEFAZODONE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NAA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA73MIRTAZAPINE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 64TCE08TACROLIMUS (IMMUNOSUPPRESSIVE) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61MCA99ANTI-CONVULSANT, N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCE10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61NCF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 60LCE83CELECOXIB (ANALGESIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 56OCA02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61PCA99ANTI-DIABETIC N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62GDC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61PCA99ANTI-DIABETIC N.E.C. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 63ACA07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 9/5/2002 | 66NIY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 66NIY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 63EIY29TICLOPIDINE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 66NIY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 62GIY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 61JIY10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 61FIY55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2002 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/6/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/6/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/6/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/13/2001 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/13/2001 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/13/2001 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pharma Exp's FDA import refusal history?
Pharma Exp (FEI: 3003206702) has 112 FDA import refusal record(s) in our database, spanning from 10/13/2001 to 10/17/2002.
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. Pharma Exp's FEI number is 3003206702.
What types of violations has Pharma Exp received?
Pharma Exp 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 Pharma Exp come from?
All FDA import refusal data for Pharma Exp 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.