Kari Brozowski
⚠️ Moderate Risk
FEI: 3010203509 • Brantford, ON • CANADA
FEI Number
3010203509
Location
Brantford, ON
Country
CANADAAddress
20 Dogwood Drive, , Brantford, 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).
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 |
|---|---|---|---|
| 6/20/2013 | 62OCA03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/20/2013 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/20/2013 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/20/2013 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/20/2013 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Kari Brozowski's FDA import refusal history?
Kari Brozowski (FEI: 3010203509) has 5 FDA import refusal record(s) in our database, spanning from 6/20/2013 to 6/20/2013.
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. Kari Brozowski's FEI number is 3010203509.
What types of violations has Kari Brozowski received?
Kari Brozowski 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 Kari Brozowski come from?
All FDA import refusal data for Kari Brozowski 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.