TEVA CANADA
⚠️ Moderate Risk
FEI: 3029667105 • Candiac, Quebec • CANADA
FEI Number
3029667105
Location
Candiac, Quebec
Country
CANADAAddress
100 De L'Industrie Blvd, , Candiac, Quebec, 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
708LISTING
It has been determined the drug is not included in a list required by Section 510(j).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2023 | 61JDB16ROSUVASTATIN CALCIUM | 3872708LISTING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TEVA CANADA's FDA import refusal history?
TEVA CANADA (FEI: 3029667105) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2023 to 11/24/2023.
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. TEVA CANADA's FEI number is 3029667105.
What types of violations has TEVA CANADA received?
TEVA CANADA 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 TEVA CANADA come from?
All FDA import refusal data for TEVA CANADA 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.