Zellers Pharmacy
⚠️ High Risk
FEI: 3003593989 • Sault Ste Marie, ON • CANADA
FEI Number
3003593989
Location
Sault Ste Marie, ON
Country
CANADAAddress
293 Bay St On, , Sault Ste Marie, ON, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 10/16/2002 | 62ODB13VERAPAMIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/1/2002 | 63BDQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 10/1/2002 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 10/1/2002 | 63BDQ01ALBUTEROL (BRONCHODILATOR) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 10/1/2002 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 9/27/2002 | 63ADB02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 9/27/2002 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 6/10/2002 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/10/2002 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/10/2002 | 65PCB57CARISOPRODOL (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/10/2002 | 66FCB05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/10/2002 | 66QCB03PROBENECID (URICOSURIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Zellers Pharmacy's FDA import refusal history?
Zellers Pharmacy (FEI: 3003593989) has 12 FDA import refusal record(s) in our database, spanning from 6/10/2002 to 10/16/2002.
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. Zellers Pharmacy's FEI number is 3003593989.
What types of violations has Zellers Pharmacy received?
Zellers Pharmacy 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 Zellers Pharmacy come from?
All FDA import refusal data for Zellers 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.