Sun Products
⚠️ Moderate Risk
FEI: 3004517531 • Puslinch, ONTARIO • CANADA
FEI Number
3004517531
Location
Puslinch, ONTARIO
Country
CANADAAddress
2053 Hwy 6 Nrr3, , Puslinch, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2004 | 62KQW10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 62KJY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New Orleans District Office (NOL-DO) | |
| 6/8/2004 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 5/13/2004 | 68YCX02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sun Products's FDA import refusal history?
Sun Products (FEI: 3004517531) has 4 FDA import refusal record(s) in our database, spanning from 5/13/2004 to 6/23/2004.
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. Sun Products's FEI number is 3004517531.
What types of violations has Sun Products received?
Sun Products 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 Sun Products come from?
All FDA import refusal data for Sun 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.