Halo Pharmaceutical Canada Inc
⚠️ Moderate Risk
FEI: 3009856628 • Mirabel, Quebec • CANADA
FEI Number
3009856628
Location
Mirabel, Quebec
Country
CANADAAddress
17800 Lapointe St, , Mirabel, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2019 | 62LCA49MEFLOQUINE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/5/2011 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/24/2008 | 64LCL08BETAMETHASONE VALERATE (GLUCOCORTICOID) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Halo Pharmaceutical Canada Inc's FDA import refusal history?
Halo Pharmaceutical Canada Inc (FEI: 3009856628) has 4 FDA import refusal record(s) in our database, spanning from 1/24/2008 to 10/28/2019.
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. Halo Pharmaceutical Canada Inc's FEI number is 3009856628.
What types of violations has Halo Pharmaceutical Canada Inc received?
Halo Pharmaceutical Canada 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 Halo Pharmaceutical Canada Inc come from?
All FDA import refusal data for Halo Pharmaceutical Canada 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.