Thomson Guardian Drugs
⚠️ High Risk
FEI: 3002932952 • Leamington, ON • CANADA
FEI Number
3002932952
Location
Leamington, ON
Country
CANADAAddress
20 Talbot St On, , Leamington, 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
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 |
|---|---|---|---|
| 1/6/2003 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2003 | 62ODB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2003 | 60LCF83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2003 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2003 | 61XAB99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2003 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Thomson Guardian Drugs's FDA import refusal history?
Thomson Guardian Drugs (FEI: 3002932952) has 6 FDA import refusal record(s) in our database, spanning from 1/6/2003 to 1/6/2003.
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. Thomson Guardian Drugs's FEI number is 3002932952.
What types of violations has Thomson Guardian Drugs received?
Thomson Guardian Drugs 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 Thomson Guardian Drugs come from?
All FDA import refusal data for Thomson Guardian Drugs 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.