Valeant Pharmaceutical
⚠️ Moderate Risk
FEI: 3008850300 • Mississauga, ON • CANADA
FEI Number
3008850300
Location
Mississauga, ON
Country
CANADAAddress
7150 Mississauga Rd, , Mississauga, ON, 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
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.
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 |
|---|---|---|---|
| 4/24/2009 | 61NAA05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/25/2005 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/3/2005 | 61NAB99ANTI-DEPRESSANT N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Valeant Pharmaceutical's FDA import refusal history?
Valeant Pharmaceutical (FEI: 3008850300) has 3 FDA import refusal record(s) in our database, spanning from 3/3/2005 to 4/24/2009.
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. Valeant Pharmaceutical's FEI number is 3008850300.
What types of violations has Valeant Pharmaceutical received?
Valeant Pharmaceutical 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 Valeant Pharmaceutical come from?
All FDA import refusal data for Valeant Pharmaceutical 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.