MORINAGA CO LTD
⚠️ Moderate Risk
FEI: 3013235753 • Minato, Tokyo • JAPAN
FEI Number
3013235753
Location
Minato, Tokyo
Country
JAPANAddress
( Kabu 5 Chome 33-1, Shiba, Minato, Tokyo, Japan
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
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)).
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.
INCONSPICU
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)).
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2024 | 33LYT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 3/8/2023 | 33UYY03NOVELTY BUBBLE GUM | Division of Southeast Imports (DSEI) | |
| 3/8/2023 | 33DGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 3/8/2023 | 33DGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 3/8/2023 | 33DGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 6/27/2019 | 03AGT03BISCUITS | 324NO ENGLISH | Division of West Coast Imports (DWCI) |
| 6/27/2019 | 03AGT03BISCUITS | 324NO ENGLISH | Division of West Coast Imports (DWCI) |
| 10/9/2018 | 33JYY99SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 11/14/2017 | 33JFT99SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/28/2017 | 03SVY23PANCAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 3/8/2017 | 33LYT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 9/29/2015 | 29YYY02EMERGENCY DRINKING WATER (CIVIL DEFENSE), SOFT DRINKS AND WATERS, N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 9/29/2015 | 33JGY15HAW CANDY | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 12/4/2006 | 09CHT03MILK, CONCENTRATED, EVAPORATED AND CONDENSED | Los Angeles District Office (LOS-DO) | |
| 9/4/2002 | 34FGN02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 218LIST INGRE | Los Angeles District Office (LOS-DO) |
| 9/4/2002 | 34FGN02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 218LIST INGRE | Los Angeles District Office (LOS-DO) |
| 4/4/2002 | 34FET02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 482NUTRIT LBL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is MORINAGA CO LTD's FDA import refusal history?
MORINAGA CO LTD (FEI: 3013235753) has 17 FDA import refusal record(s) in our database, spanning from 4/4/2002 to 7/15/2024.
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. MORINAGA CO LTD's FEI number is 3013235753.
What types of violations has MORINAGA CO LTD received?
MORINAGA CO 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 MORINAGA CO LTD come from?
All FDA import refusal data for MORINAGA 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.