Anda Medical 3964191 Canada In
⚠️ Moderate Risk
FEI: 3004449589 • Nepean, ON • CANADA
FEI Number
3004449589
Location
Nepean, ON
Country
CANADAAddress
21 Donnington Pl, , Nepean, 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).
Refusal History
Frequently Asked Questions
What is Anda Medical 3964191 Canada In's FDA import refusal history?
Anda Medical 3964191 Canada In (FEI: 3004449589) has 2 FDA import refusal record(s) in our database, spanning from 11/28/2005 to 11/28/2005.
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. Anda Medical 3964191 Canada In's FEI number is 3004449589.
What types of violations has Anda Medical 3964191 Canada In received?
Anda Medical 3964191 Canada In 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 Anda Medical 3964191 Canada In come from?
All FDA import refusal data for Anda Medical 3964191 Canada In 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.