Seven Seas Limited
⚠️ Moderate Risk
FEI: 3004657751 • Hull, KHL • UNITED KINGDOM
FEI Number
3004657751
Location
Hull, KHL
Country
UNITED KINGDOMAddress
1301 Hedon Road, Marfleet; Gb-Khl, Hull, KHL, 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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 |
|---|---|---|---|
| 10/4/2016 | 54HCH05OMEGA-3 (FATS AND LIPID SUBSTANCES) | Division of Southeast Imports (DSEI) | |
| 10/4/2016 | 54HCH05OMEGA-3 (FATS AND LIPID SUBSTANCES) | Division of Southeast Imports (DSEI) | |
| 12/27/2011 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New Orleans District Office (NOL-DO) | |
| 10/28/2011 | 54ABR99VITAMIN, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 6/8/2009 | 66YCB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/12/2007 | 54ACL99VITAMIN, N.E.C. | New York District Office (NYK-DO) | |
| 1/12/2007 | 54ACL99VITAMIN, N.E.C. | New York District Office (NYK-DO) | |
| 11/6/2006 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Seven Seas Limited's FDA import refusal history?
Seven Seas Limited (FEI: 3004657751) has 10 FDA import refusal record(s) in our database, spanning from 9/21/2005 to 10/4/2016.
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. Seven Seas Limited's FEI number is 3004657751.
What types of violations has Seven Seas Limited received?
Seven Seas Limited 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 Seven Seas Limited come from?
All FDA import refusal data for Seven Seas 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.