Koolatron Div Urus Indus
⚠️ Moderate Risk
FEI: 3002117852 • Brantford, Ontario • CANADA
FEI Number
3002117852
Location
Brantford, Ontario
Country
CANADAAddress
27 Catharine Ave, , Brantford, Ontario, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/11/2011 | 76MMDTOOTHBRUSH, IONIC, BATTERY-POWERED | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/21/2003 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/21/2003 | 61HAL18AMINOSALICYLIC ACID (ANTI-BACTERIAL) | New York District Office (NYK-DO) | |
| 5/2/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Koolatron Div Urus Indus's FDA import refusal history?
Koolatron Div Urus Indus (FEI: 3002117852) has 4 FDA import refusal record(s) in our database, spanning from 5/2/2002 to 1/11/2011.
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. Koolatron Div Urus Indus's FEI number is 3002117852.
What types of violations has Koolatron Div Urus Indus received?
Koolatron Div Urus Indus has been cited for 5 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 Koolatron Div Urus Indus come from?
All FDA import refusal data for Koolatron Div Urus Indus 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.