Equine Solution
⚠️ Moderate Risk
FEI: 3009439500 • Waterdown, Ontario • CANADA
FEI Number
3009439500
Location
Waterdown, Ontario
Country
CANADAAddress
255 Dundas East, Po Box 82061, Waterdown, 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 2/13/2013 | 65SOL01RUBBING ALCOHOL (RUBEFACIENT) | New York District Office (NYK-DO) | |
| 2/13/2013 | 55QY16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT) | New York District Office (NYK-DO) | |
| 2/13/2013 | 68YBL02HORSES ANIMAL DRUGS N.E.C. | New York District Office (NYK-DO) | |
| 2/13/2013 | 68YBL02HORSES ANIMAL DRUGS N.E.C. | New York District Office (NYK-DO) | |
| 2/13/2013 | 68YBL02HORSES ANIMAL DRUGS N.E.C. | New York District Office (NYK-DO) | |
| 2/13/2013 | 68GBR02HORSES NUTRIENT | New York District Office (NYK-DO) | |
| 2/13/2013 | 68YAY02HORSES ANIMAL DRUGS N.E.C. | New York District Office (NYK-DO) | |
| 2/13/2013 | 62GAY99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Equine Solution's FDA import refusal history?
Equine Solution (FEI: 3009439500) has 8 FDA import refusal record(s) in our database, spanning from 2/13/2013 to 2/13/2013.
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. Equine Solution's FEI number is 3009439500.
What types of violations has Equine Solution received?
Equine Solution has been cited for 4 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 Equine Solution come from?
All FDA import refusal data for Equine Solution 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.