Rose Janzen
⚠️ High Risk
FEI: 3007041622 • Tillsonburg, ON • CANADA
FEI Number
3007041622
Location
Tillsonburg, ON
Country
CANADAAddress
75 Tillson Ave, , Tillsonburg, 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 |
|---|---|---|---|
| 9/2/2008 | 61PCY54LISPRO INSULIN (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 64NCA05FERROUS GLUCONATE (HEMATINIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 65RCA14POTASSIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 60LCA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 62TAE02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 61PCA62PIOGLITAZONE HCL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2008 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Rose Janzen's FDA import refusal history?
Rose Janzen (FEI: 3007041622) has 11 FDA import refusal record(s) in our database, spanning from 9/2/2008 to 9/2/2008.
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. Rose Janzen's FEI number is 3007041622.
What types of violations has Rose Janzen received?
Rose Janzen 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 Rose Janzen come from?
All FDA import refusal data for Rose Janzen 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.