Aromesse Ltd
⚠️ Moderate Risk
FEI: 3005215348 • Gainsborough, Lincolnshire • UNITED KINGDOM
FEI Number
3005215348
Location
Gainsborough, Lincolnshire
Country
UNITED KINGDOMAddress
Croft Farm, , Gainsborough, Lincolnshire, 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
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 7/14/2020 | 68ZHG99ANIMAL MEDICAL DEVICES, NEC | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 68ZHG99ANIMAL MEDICAL DEVICES, NEC | Division of Southeast Imports (DSEI) | |
| 4/30/2013 | 68CDL20ANTISEPTIC USED MORE THAN 1 SPECIES | Cincinnati District Office (CIN-DO) | |
| 8/1/2008 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 8/1/2008 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 8/1/2008 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 8/1/2008 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 8/1/2008 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 483DRUG NAME | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aromesse Ltd's FDA import refusal history?
Aromesse Ltd (FEI: 3005215348) has 9 FDA import refusal record(s) in our database, spanning from 8/1/2008 to 9/23/2020.
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. Aromesse Ltd's FEI number is 3005215348.
What types of violations has Aromesse Ltd received?
Aromesse Ltd has been cited for 4 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 Aromesse Ltd come from?
All FDA import refusal data for Aromesse 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.