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  5. Marukyo Co., Ltd. - 571305 - 03/14/2019
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Marukyo Co., Ltd. MARCS-CMS 571305 —

Food & Beverages

Recipient Name
Mr. Hiroo Sumi
Recipient Title
Marukyo Co., Ltd.

2002-2, Hatagasaki
Yonago, Tottori

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States


MAR 14, 2019





Mr. Hiroo Sumi, President

Marukyo Co., Ltd.

2002-2, Hatagasaki

Yonago, Tottori, 683-0845


Reference No. 571305


Dear Mr. Hiroo Sumi:

The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) product facility located at 2002-2, Hatagasaki, Yonago, Tottori 683-0845 Japan on September 13-14, 2018. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation Part 113 (21 CFR 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm. We acknowledge your response to the FDA-483 received via email on October 1, 2018 and additional response to our follow-up questions on December 6, 2018. Our evaluation revealed that your responses were not adequate, as further described in this letter. 

As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of  21 CFR 108.35 and 21 CFR 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Consequently, your violations of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and LACF regulations through links in FDA’s home page at www.fda.gov.

Your significant violation is as follows:

You must file with the FDA the scheduled processes for each low-acid food in each container size to comply with 21 CFR 108.35(c)(2). These filings must occur not later than 60 days after registration and prior to the packing of a new product. For LACF products, these must include the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each product in each container size. Specifically, during the current inspection, it was determined that your firm has manufactured, packed and distributed various LACF products without registering and filing scheduled processes with the FDA.

Your Dorayaki products in various flavors consist of red bean paste sandwiched between two baked wheat cakes.  Based on our review of your finished product testing for water activity (Aw) conducted by your (b)(4) laboratory for these products, the finished product Aw values were (b)(4). You seal your finished products in reduced oxygen packaging, creating a hermetic seal. You store your finished products at ambient room temperature for (b)(4) days after packaging, before being transported to a refrigerated warehouse. Your firm explained to our investigator that the products are then shipped frozen to the US. You further explained that when the frozen product arrives in the U.S., it is thawed, distributed refrigerated and stored in retail markets at ambient or refrigerated temperatures. Your labeling states “(b)(4) KEEP REFRIGERATED and consume within 90 days”.  Consequently, it appears that your firm is not following the handling instructions on the labels of your products, in that you are not continuously maintaining the products under refrigerated conditions.

Regarding your products as low-acid foods and subject to the requirements under 21 CFR 108.35 and 21 CFR 113, during our previous inspection conducted on November 14-15, 2013, you provided pH values for your Dorayaki products ranging from approximately (b)(4). Though you no longer analyze your finished products for pH, there have been no changes to your process which would lower your product pH to (b)(4) or below.  Because your Dorayaki products have finished pH levels above (b)(4) and Aw values above (b)(4), your products are considered low-acid foods. Additionally, your products are packaged in reduced oxygen packaging (ROP) and are stored at ambient temperatures for (b)(4) days after packaging. Your products fall under the FDA’s Low Acid Canned Foods (LACF) regulations, and as such, would need to have scheduled processes developed by a Process Authority.

More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.

Your September 30, 2018, response to the FDA 483 described your corrective measures, including modifying your label to state, “(b)(4)” and adding a requirement for refrigerated storage of your product “(b)(4)”. We replied on November 27, 2018 with questions regarding the specific time limit from packaging to refrigeration and, whether there are any established critical control points (CCPs) in your HACCP plan for your Dorayaki products to cover labeling (i.e., “(b)(4)”) or refrigerated storage or freezing after packaging while held at your facility. We also requested documents such as your revised HACCP plan. You responded on December 6, 2018, to our questions and provided documents including your revised HACCP plan. You also stated that you were in the process of filing SIDs and you think there is no risk of Clostridium botulinum in your product because the water activity values are under (b)(4). Although low water activity prevents the spores from germinating, it does not kill Clostridium botulinum. Commercial sterility is achieved by controlling the water activity and the application of heat to kill vegetative pathogens.

Our review of your responses finds that your HACCP plan (b)(4). Holding, transporting, and distributing your products frozen or under refrigeration at your facility, and labeling your products to “(b)(4)” or “(b)(4)” would exclude these products from the regulations cited above.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for five lots of product produced over at least five days. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. Responding in English will help to assist us in our review of your documentation.

If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF products under section 801(a) of the Act (21 U.S.C. 381(a)) including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, examples of Import Alerts that convey information specific to foreign firms that are not in compliance with the LACF and acidified food regulations (21 CFR 108, 113 and 114) are Import Alert #99-37, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods without Filed Scheduled Processes and Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. These alerts can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Acidified regulations (21 CFR 108 and 114), and the current Good Manufacturing Practices regulation (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration. 

Additionally, section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.

Please send your reply to the Food and Drug Administration, Attention: Aleta Flores, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Aleta Flores via email at aleta.flores@fda.hhs.gov. Please reference 571305 on any submissions and within the subject line of any emails to us.





William A. Correll, Jr.


Office of Compliance

Center for Food Safety

       and Applied Nutrition

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