Elanco UK AH Limited
⚠️ Moderate Risk
FEI: 3003701830 • Liverpool, Merseyside • UNITED KINGDOM
FEI Number
3003701830
Location
Liverpool, Merseyside
Country
UNITED KINGDOMAddress
Fleming Road, , Speke, Liverpool, Merseyside, 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
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2006 | 69BD87TILMICOSIN, CATEGORY II, MEDICATED ANIMAL FEED | 72NEW VET DR | Florida District Office (FLA-DO) |
| 12/27/2005 | 56IJK99MACROLIDE, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/17/2005 | 67B99CATEGORY II, N.E.C., TYPE A MEDICATED ARTICLE | Division of Southeast Imports (DSEI) | |
| 1/18/2005 | 67B99CATEGORY II, N.E.C., TYPE A MEDICATED ARTICLE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/8/2004 | 67B99CATEGORY II, N.E.C., TYPE A MEDICATED ARTICLE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/5/2004 | 69BD87TILMICOSIN, CATEGORY II, MEDICATED ANIMAL FEED | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2004 | 69BD87TILMICOSIN, CATEGORY II, MEDICATED ANIMAL FEED | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2004 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/20/2004 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/28/2004 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/28/2004 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/21/2004 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/19/2003 | 68FAF01CATTLE HORMONES | 72NEW VET DR | Florida District Office (FLA-DO) |
| 10/9/2003 | 68FAF01CATTLE HORMONES | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/16/2003 | 68FAF01CATTLE HORMONES | Florida District Office (FLA-DO) | |
| 8/15/2003 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/20/2003 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Florida District Office (FLA-DO) |
| 12/2/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/10/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Florida District Office (FLA-DO) |
| 8/13/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Florida District Office (FLA-DO) |
| 8/7/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/7/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Florida District Office (FLA-DO) |
| 7/10/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Florida District Office (FLA-DO) |
| 6/20/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/27/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/25/2002 | 68YAS05SWINE ANIMAL DRUGS N.E.C. | 72NEW VET DR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Elanco UK AH Limited's FDA import refusal history?
Elanco UK AH Limited (FEI: 3003701830) has 29 FDA import refusal record(s) in our database, spanning from 3/25/2002 to 5/16/2006.
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. Elanco UK AH Limited's FEI number is 3003701830.
What types of violations has Elanco UK AH Limited received?
Elanco UK AH Limited has been cited for 7 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 Elanco UK AH Limited come from?
All FDA import refusal data for Elanco UK AH Limited 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.