Hunters Pharmacy
⚠️ Moderate Risk
FEI: 3001597917 • Windsor, ON • CANADA
FEI Number
3001597917
Location
Windsor, ON
Country
CANADAAddress
3019 Tecumseh St E, , Windsor, 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
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 |
|---|---|---|---|
| 10/21/2019 | 61KCC48TOFENACIN HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2019 | 61KCC48TOFENACIN HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2003 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/18/2003 | 62KDB99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/18/2003 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/18/2003 | 64BDB40TRIAMTERENE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hunters Pharmacy's FDA import refusal history?
Hunters Pharmacy (FEI: 3001597917) has 6 FDA import refusal record(s) in our database, spanning from 4/18/2003 to 10/21/2019.
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. Hunters Pharmacy's FEI number is 3001597917.
What types of violations has Hunters Pharmacy received?
Hunters Pharmacy 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 Hunters Pharmacy come from?
All FDA import refusal data for Hunters Pharmacy 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.