Enviro Fresh Products
⚠️ Moderate Risk
FEI: 3006601547 • North York, ON • CANADA
FEI Number
3006601547
Location
North York, ON
Country
CANADAAddress
618 Magnetic Dr, , North York, 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
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2008 | 68IBL20TONIC USED MORE THAN 1 SPECIES | Detroit District Office (DET-DO) | |
| 10/28/2008 | 68YBL20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | Detroit District Office (DET-DO) | |
| 10/28/2008 | 68YBL20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | Detroit District Office (DET-DO) | |
| 10/28/2008 | 68YBL20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | Detroit District Office (DET-DO) | |
| 10/28/2008 | 68YBL20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Enviro Fresh Products's FDA import refusal history?
Enviro Fresh Products (FEI: 3006601547) has 5 FDA import refusal record(s) in our database, spanning from 10/28/2008 to 12/17/2008.
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. Enviro Fresh Products's FEI number is 3006601547.
What types of violations has Enviro Fresh Products received?
Enviro Fresh Products has been cited for 3 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 Enviro Fresh Products come from?
All FDA import refusal data for Enviro Fresh Products 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.