Ardena U.S. LLC
⚠️ Moderate Risk
FEI: 3003563645 • Somerset, NJ • UNITED STATES
FEI Number
3003563645
Location
Somerset, NJ
Country
UNITED STATESAddress
14 Schoolhouse Rd, , Somerset, NJ, United States
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2017 | 68XCA99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 68XCA99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 68BBB10SMALL ANIMAL ANTI-INFECTIVE | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 68XIY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 5/31/2012 | 62IQA99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 5/31/2012 | 62IQA99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 5/30/2012 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 5/30/2012 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 4/6/2012 | 62IQB99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/3/2011 | 62IQB99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/3/2011 | 62IQB99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 8/26/2011 | 62IQA99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 8/26/2011 | 62IQA99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 3/25/2011 | 62IQS99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 3/25/2011 | 62IQS99ANTI-NEOPLASTIC N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ardena U.S. LLC's FDA import refusal history?
Ardena U.S. LLC (FEI: 3003563645) has 15 FDA import refusal record(s) in our database, spanning from 3/25/2011 to 3/21/2017.
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. Ardena U.S. LLC's FEI number is 3003563645.
What types of violations has Ardena U.S. LLC received?
Ardena U.S. LLC has been cited for 1 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 Ardena U.S. LLC come from?
All FDA import refusal data for Ardena U.S. LLC 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.