Abbey Export Ltd
⚠️ Moderate Risk
FEI: 1000645519 • Leeds • UNITED KINGDOM
FEI Number
1000645519
Location
Leeds
Country
UNITED KINGDOMAddress
Sherburn Enterprise Park Aviation Way, , Leeds, , United Kingdom
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2008 | 68YCE20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 1/16/2008 | 68YIP10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Philadelphia District Office (PHI-DO) |
| 12/7/2007 | 68YCL99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | New York District Office (NYK-DO) | |
| 12/7/2007 | 68YCY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | New York District Office (NYK-DO) | |
| 10/12/2007 | 68YAZ20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | New York District Office (NYK-DO) | |
| 5/3/2007 | 60QQW99ANESTHETIC, N.E.C. | New York District Office (NYK-DO) | |
| 10/8/2003 | 68JDK10SMALL ANIMAL TRANQUILIZER/ATARAXIC | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 9/15/2003 | 68YIH20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Abbey Export Ltd's FDA import refusal history?
Abbey Export Ltd (FEI: 1000645519) has 8 FDA import refusal record(s) in our database, spanning from 9/15/2003 to 6/23/2008.
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. Abbey Export Ltd's FEI number is 1000645519.
What types of violations has Abbey Export Ltd received?
Abbey Export Ltd 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 Abbey Export Ltd come from?
All FDA import refusal data for Abbey Export Ltd 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.