Biorthex Inc
✅ Low Risk
FEI: 3002790509 • Montreal, Quebec • CANADA
FEI Number
3002790509
Location
Montreal, Quebec
Country
CANADAAddress
9001 De L'Acadie Blvd Bureau 902, , Montreal, Quebec, Canada
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Biorthex Inc's FDA import refusal history?
Biorthex Inc (FEI: 3002790509) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2002 to 6/17/2002.
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. Biorthex Inc's FEI number is 3002790509.
What types of violations has Biorthex Inc received?
Biorthex 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 Biorthex Inc come from?
All FDA import refusal data for Biorthex 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.