SIVEM PHARMACEUTICALS
⚠️ High Risk
FEI: 3014390867 • Saint-Laurent, Quebec • CANADA
FEI Number
3014390867
Location
Saint-Laurent, Quebec
Country
CANADAAddress
4800 Levy St, , Saint-Laurent, Quebec, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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 |
|---|---|---|---|
| 8/30/2022 | 63ADY07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2022 | 62ODY03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2022 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2022 | 61NDY69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2022 | 62ODY18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2022 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SIVEM PHARMACEUTICALS's FDA import refusal history?
SIVEM PHARMACEUTICALS (FEI: 3014390867) has 6 FDA import refusal record(s) in our database, spanning from 8/30/2022 to 8/30/2022.
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. SIVEM PHARMACEUTICALS's FEI number is 3014390867.
What types of violations has SIVEM PHARMACEUTICALS received?
SIVEM PHARMACEUTICALS 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 SIVEM PHARMACEUTICALS come from?
All FDA import refusal data for SIVEM PHARMACEUTICALS 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.