HILTON HERBS LTD
⚠️ High Risk
FEI: 3004653802 • Crewkerne, Somerset • UNITED KINGDOM
FEI Number
3004653802
Location
Crewkerne, Somerset
Country
UNITED KINGDOMAddress
Downclose Farm, Downclose Lane, Crewkerne, Somerset, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2025 | 54EML84MILK THISTLE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 66VPJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 66VPJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 66VPJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 54KNL08ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 66VPJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 66VPJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 54FML84MILK THISTLE (HERBAL & BOTANICAL OTHER THAN TEAS) | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 54FML84MILK THISTLE (HERBAL & BOTANICAL OTHER THAN TEAS) | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 54KML08ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 54EYY84MILK THISTLE | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/13/2022 | 54ENY84MILK THISTLE | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/3/2022 | 54EYY84MILK THISTLE | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/3/2022 | 54EYY84MILK THISTLE | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/3/2022 | 54ENY84MILK THISTLE | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/19/2016 | 66YRY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 1/20/2012 | 72AYT99PET CAT FOOD N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/1/2009 | 70MY99MIXED FEED RATION FOR ANIMALS, N.E.C. | 72NEW VET DR | Baltimore District Office (BLT-DO) |
| 12/1/2009 | 70MY99MIXED FEED RATION FOR ANIMALS, N.E.C. | 72NEW VET DR | Baltimore District Office (BLT-DO) |
| 12/1/2009 | 70MY99MIXED FEED RATION FOR ANIMALS, N.E.C. | 72NEW VET DR | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is HILTON HERBS LTD's FDA import refusal history?
HILTON HERBS LTD (FEI: 3004653802) has 20 FDA import refusal record(s) in our database, spanning from 12/1/2009 to 4/24/2025.
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. HILTON HERBS LTD's FEI number is 3004653802.
What types of violations has HILTON HERBS LTD received?
HILTON HERBS LTD has been cited for 6 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 HILTON HERBS LTD come from?
All FDA import refusal data for HILTON HERBS 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.