Arkopharma Canada Inc
⚠️ Moderate Risk
FEI: 3006101271 • Boisbriand, QC • CANADA
FEI Number
3006101271
Location
Boisbriand, QC
Country
CANADAAddress
1933 Lionnel Bertrand, , Boisbriand, QC, 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).
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).
Refusal History
Frequently Asked Questions
What is Arkopharma Canada Inc's FDA import refusal history?
Arkopharma Canada Inc (FEI: 3006101271) has 2 FDA import refusal record(s) in our database, spanning from 4/5/2007 to 4/5/2007.
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. Arkopharma Canada Inc's FEI number is 3006101271.
What types of violations has Arkopharma Canada Inc received?
Arkopharma Canada Inc has been cited for 2 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 Arkopharma Canada Inc come from?
All FDA import refusal data for Arkopharma Canada 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.