Medisca Pharmaceutique Inc.
⚠️ Moderate Risk
FEI: 3000305308 • Saint-Laurent, Quebec • CANADA
FEI Number
3000305308
Location
Saint-Laurent, Quebec
Country
CANADAAddress
4509 Dobrin St, , Saint-Laurent, 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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2015 | 62TCR02LANSOPRAZOLE (ANTI-SECRETORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/24/2009 | 55RP44POLYETHYLENE GLYCOL 6000 (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | New York District Office (NYK-DO) | |
| 2/24/2009 | 55RP44POLYETHYLENE GLYCOL 6000 (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | New York District Office (NYK-DO) | |
| 2/24/2009 | 55RP44POLYETHYLENE GLYCOL 6000 (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | New York District Office (NYK-DO) | |
| 2/24/2009 | 55PP04POLOXAMER 182LF (PHARMACEUTIC NECESSITY) | New York District Office (NYK-DO) | |
| 2/24/2009 | 55PP04POLOXAMER 182LF (PHARMACEUTIC NECESSITY) | New York District Office (NYK-DO) | |
| 2/24/2009 | 55PP04POLOXAMER 182LF (PHARMACEUTIC NECESSITY) | New York District Office (NYK-DO) | |
| 2/24/2009 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | New York District Office (NYK-DO) | |
| 2/24/2009 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | New York District Office (NYK-DO) | |
| 5/10/2005 | 64XAR12TRETINOIN (KERATOLYTIC) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/29/2002 | 61NCS03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/29/2002 | 64BCS41TRICHLORMETHIAZIDE (DIURETIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/20/2002 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/17/2002 | 62LCY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Cincinnati District Office (CIN-DO) | |
| 2/17/2002 | 64BCY37SPIRONOLACTONE (DIURETIC) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Medisca Pharmaceutique Inc.'s FDA import refusal history?
Medisca Pharmaceutique Inc. (FEI: 3000305308) has 15 FDA import refusal record(s) in our database, spanning from 2/17/2002 to 6/29/2015.
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. Medisca Pharmaceutique Inc.'s FEI number is 3000305308.
What types of violations has Medisca Pharmaceutique Inc. received?
Medisca Pharmaceutique 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 Medisca Pharmaceutique Inc. come from?
All FDA import refusal data for Medisca Pharmaceutique 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.