Ocean Leader Co Ltd
⚠️ Moderate Risk
FEI: 1000140804 • Taipei • TAIWAN
FEI Number
1000140804
Location
Taipei
Country
TAIWANAddress
4f No 19 Lane 550 Min Chuan E Road, Box 101-138, Taipei, , Taiwan
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
HISTAMINE
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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)).
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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.
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.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2013 | 16AFD51MAHI MAHI | Los Angeles District Office (LOS-DO) | |
| 9/18/2007 | 16AGT51MAHI MAHI | Florida District Office (FLA-DO) | |
| 9/18/2007 | 16AGT51MAHI MAHI | Florida District Office (FLA-DO) | |
| 12/1/2005 | 16AGT51MAHI MAHI | 2360HISTAMINE | Division of Southeast Imports (DSEI) |
| 12/1/2005 | 16AGT51MAHI MAHI | 2360HISTAMINE | Division of Southeast Imports (DSEI) |
| 11/9/2004 | 16AGT10CATFISH, FRESHWATER (E.G. CHANNEL, BLUE, WHITE, YAQUI, BULLHEAD, FLATHEAD CATFISH) | 473LABELING | Florida District Office (FLA-DO) |
| 11/3/2004 | 16AGT51MAHI MAHI | Florida District Office (FLA-DO) | |
| 11/3/2004 | 16AGT51MAHI MAHI | Florida District Office (FLA-DO) | |
| 4/13/2004 | 16AGD51MAHI MAHI | Florida District Office (FLA-DO) | |
| 6/27/2002 | 16AGT51MAHI MAHI | Los Angeles District Office (LOS-DO) | |
| 5/3/2002 | 16AGC51MAHI MAHI | 2360HISTAMINE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ocean Leader Co Ltd's FDA import refusal history?
Ocean Leader Co Ltd (FEI: 1000140804) has 11 FDA import refusal record(s) in our database, spanning from 5/3/2002 to 10/16/2013.
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. Ocean Leader Co Ltd's FEI number is 1000140804.
What types of violations has Ocean Leader Co Ltd received?
Ocean Leader Co Ltd has been cited for 9 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 Ocean Leader Co Ltd come from?
All FDA import refusal data for Ocean Leader Co 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.