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MORINAGA CO LTD

⚠️ Moderate Risk

FEI: 3013235753 • Minato, Tokyo • JAPAN

FEI

FEI Number

3013235753

📍

Location

Minato, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

( Kabu 5 Chome 33-1, Shiba, Minato, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

17
Total Refusals
6
Unique Violations
7/15/2024
Latest Refusal
4/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
37.7×40%
Refusal Volume
46.5×30%
Recency
69.8×20%
Frequency
7.6×10%
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

3249×

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)).

4825×

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.

2564×

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)).

2182×

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.

621×

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).

831×

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

DateProductViolationsDivision
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
256INCONSPICU
482NUTRIT LBL
Division of Southeast Imports (DSEI)
3/8/2023
33DGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE)
256INCONSPICU
482NUTRIT LBL
Division of Southeast Imports (DSEI)
3/8/2023
33DGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE)
256INCONSPICU
482NUTRIT LBL
Division of Southeast Imports (DSEI)
3/8/2023
33DGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE)
256INCONSPICU
482NUTRIT LBL
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
62NEEDS FCE
83NO PROCESS
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.