Unknown
⚠️ Moderate Risk
FEI: 3014387478 • Unknown, Ontario • CANADA
FEI Number
3014387478
Location
Unknown, Ontario
Country
CANADAAddress
Unknown, , Unknown, Ontario, 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
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 |
|---|---|---|---|
| 1/16/2007 | 64SCA29ZOPICLONE | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/16/2007 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/1/2006 | 64GCA28ESTROGENS CONJUGATED (ESTROGEN) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/1/2006 | 64SCA29ZOPICLONE | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/1/2006 | 61NCE29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/30/2002 | 61JDA13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2002 | 61NCA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Unknown's FDA import refusal history?
Unknown (FEI: 3014387478) has 7 FDA import refusal record(s) in our database, spanning from 2/25/2002 to 1/16/2007.
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. Unknown's FEI number is 3014387478.
What types of violations has Unknown received?
Unknown has been cited for 1 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 Unknown come from?
All FDA import refusal data for Unknown 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.