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Marukyo Co., Ltd.

FDA import alert and refusal historyYonago, JapanFEI 1000275076

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Example subjectMarukyo Co., Ltd added to Import Alert 16-129 (red list)

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As of October 27, 2026, Marukyo Co., Ltd. (Yonago, Japan) is on the red list of FDA Import Alert 99-37 (Low-acid canned/acidified foods without scheduled process) for funwariyaki red bean cake; dorayaki red bean cake, published by FDA on December 14, 2022, and has 12 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
IA 99-37 · red list
Last import refusal
Cakes, filled (other than fruit or jelly) · NO PROCESS
Last warning letter
None found
Last inspection
Classified OAI (Official Action Indicated)

Every FDA record for Marukyo Co., Ltd.

16 records, newest first. Each line links to the FDA page it came from.

2025

  1. Import refusal
    Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-4209563-1
    Source

2023

  1. Import refusal
    Refused, 2 lines in one entry: Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-4038110-8Show 2 lines
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-4038110-8Source
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-4038110-8Source
    Source
  2. Import refusal
    Refused, 3 lines in one entry: Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8964350-9Show 3 lines
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8964350-9Source
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8964350-9Source
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8964350-9Source
    Source
  3. Import refusal
    Refused, 2 lines in one entry: Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8953535-8Show 2 lines
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8953535-8Source
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8953535-8Source
    Source
  4. Import refusal
    Refused, 2 lines in one entry: Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8947561-3Show 2 lines
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8947561-3Source
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8947561-3Source
    Source
  5. Import refusal
    Refused, 2 lines in one entry: Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8947563-9Show 2 lines
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8947563-9Source
    • Refused, Cakes, filled (other than fruit or jelly)NO PROCESSEntry 510-8947563-9Source
    Source

2022

  1. Import alert listing
    Listed on Import Alert 99-37red listFunwariyaki Red bean cake; Dorayaki Red bean cake
    Source
  2. Inspection
    Inspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
    Source

2018

  1. Inspection
    Inspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
    Source

2013

  1. Inspection
    Inspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
    Source

Refusal charges, in plain English

  • NO PROCESS12 refused lines

    No scheduled process filed

    The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.

Questions about Marukyo Co., Ltd.

Is Marukyo Co., Ltd. on an FDA import alert?
Yes. As of October 27, 2026, Marukyo Co., Ltd. is on the red list of FDA Import Alert 99-37, “Low-acid canned/acidified foods without scheduled process”, for funwariyaki red bean cake; dorayaki red bean cake; FDA published the listing on December 14, 2022.
Has FDA refused shipments from Marukyo Co., Ltd.?
Yes. FDA refused 12 shipment lines from Marukyo Co., Ltd. between March 10, 2023 and April 25, 2025. The most recent, on April 25, 2025, was cakes, filled (other than fruit or jelly), charged as NO PROCESS (no scheduled process filed).
Why did FDA refuse Marukyo Co., Ltd.'s shipments?
The most frequent charge is NO PROCESS (no scheduled process filed, 12 lines).
When was Marukyo Co., Ltd. last inspected by FDA?
FDA's most recent inspection of Marukyo Co., Ltd. with a final classification is dated September 14, 2022 and was classified OAI (Official Action Indicated).
What is Marukyo Co., Ltd.'s FEI number?
Marukyo Co., Ltd.'s FDA Establishment Identifier (FEI) is 1000275076.
Can shipments from Marukyo Co., Ltd. still enter the U.S.?
Shipments of funwariyaki red bean cake; dorayaki red bean cake from Marukyo Co., Ltd. can be detained without physical examination under Import Alert 99-37; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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Example subjectMarukyo Co., Ltd added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.