ZANDOZ CANADA
⚠️ Moderate Risk
FEI: 3012743750 • Boucherville, Quebec • CANADA
FEI Number
3012743750
Location
Boucherville, Quebec
Country
CANADAAddress
145 Jules-Leger St, , Boucherville, 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
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 |
|---|---|---|---|
| 1/12/2021 | 64RDY21SOMATROPIN (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2019 | 62ODK26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2019 | 62CCK99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2019 | 62ODK26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2019 | 62CCK99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 62ODB03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZANDOZ CANADA's FDA import refusal history?
ZANDOZ CANADA (FEI: 3012743750) has 6 FDA import refusal record(s) in our database, spanning from 5/10/2019 to 1/12/2021.
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. ZANDOZ CANADA's FEI number is 3012743750.
What types of violations has ZANDOZ CANADA received?
ZANDOZ 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 ZANDOZ CANADA come from?
All FDA import refusal data for ZANDOZ 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.