Immunall Ltd
⚠️ Moderate Risk
FEI: 3009239986 • East Wincheast Winch • UNITED KINGDOM
FEI Number
3009239986
Location
East Wincheast Winch
Country
UNITED KINGDOMAddress
Heathlands Farm Ashwicken Roadashwicken, , East Wincheast Winch, , 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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2015 | 70MY02HORSE MIXED FEED RATION | Cincinnati District Office (CIN-DO) | |
| 4/14/2015 | 70MY02HORSE MIXED FEED RATION | Cincinnati District Office (CIN-DO) | |
| 10/16/2012 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 2/22/2012 | 66VKL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 2/21/2012 | 66VKL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 1/24/2012 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 1/24/2012 | 66VKL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Immunall Ltd's FDA import refusal history?
Immunall Ltd (FEI: 3009239986) has 7 FDA import refusal record(s) in our database, spanning from 1/24/2012 to 4/14/2015.
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. Immunall Ltd's FEI number is 3009239986.
What types of violations has Immunall Ltd received?
Immunall 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 Immunall Ltd come from?
All FDA import refusal data for Immunall 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.