Eurocaps Limited
⚠️ Moderate Risk
FEI: 3004315762 • Tredegar, None of the above • UNITED KINGDOM
FEI Number
3004315762
Location
Tredegar, None of the above
Country
UNITED KINGDOMAddress
Crown Business Park, , Tredegar, None of the above, 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
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.
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).
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2021 | 54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/23/2021 | 54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/23/2021 | 54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/23/2021 | 54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/23/2021 | 54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/29/2018 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Southeast Imports (DSEI) |
| 10/10/2018 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Southeast Imports (DSEI) |
| 10/4/2018 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/22/2018 | 54YBC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Southeast Imports (DSEI) |
| 6/22/2018 | 54YBC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Southeast Imports (DSEI) |
| 3/1/2017 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 260FALSE | Division of Southeast Imports (DSEI) |
| 5/31/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/31/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/5/2016 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 2/25/2016 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Southeast Imports (DSEI) |
| 12/15/2005 | 54ACB90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Eurocaps Limited's FDA import refusal history?
Eurocaps Limited (FEI: 3004315762) has 16 FDA import refusal record(s) in our database, spanning from 12/15/2005 to 7/23/2021.
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. Eurocaps Limited's FEI number is 3004315762.
What types of violations has Eurocaps Limited received?
Eurocaps Limited has been cited for 8 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 Eurocaps Limited come from?
All FDA import refusal data for Eurocaps 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.