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WARNING LETTER

Marumo Co., Ltd. MARCS-CMS 658697 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Tametsugu Oshige
Recipient Title
President and CEO
Marumo Co., Ltd.

2-1-4, Taniyama-Ko
Kagoshima-shi, Kagoshima
891-0131
Japan

fukudome@kk-marumo.co.jp
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

June 30, 2023

WARNING LETTER

Reference # 658697

Dear Mr. Oshige:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Marumo Co., Ltd. located at 2-1-4, Taniyama-Ko, Kagoshima-shi, Kagoshima, Japan on January 25 through January 26, 2023. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on February 15 and 16, 2023. Your response included descriptions of corrections and a study titled, “Experiment Report.” However, our evaluation of your response revealed it was not adequate, as further described in this letter.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your dried shaved skipjack tuna (bonito)products are adulterated, in that they have been prepared, packed or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The 4th Edition of the Hazards Guide can be found on our web site at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm

Your significant violations are as follows:

1. You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s Seafood HACCP plan dated January 6, 2023, for dried, shaved skipjack tuna in ROP 80g and 2gx20 multi-pack packages does not identify the hazard of pathogenic bacteria including Staphylococcus aureus (S. aureus) and Clostridium botulinum (C. botulinum) growth and toxin formation before, during, and after rehydration of dried skipjack tuna chunks.

You rehydrate dried skipjack tuna chunks by (b)(4) them in water for at least (b)(4) prior to (b)(4) cooking. You have not implemented controls to ensure the water activity (Aw) is less than 0.85 to prevent pathogenic bacteria growth and toxin formation during your (b)(4) steps. The product is cooled overnight in a (b)(4)°C / (b)(4)°F storage room. You also have not implemented controls to ensure the Aw is less than 0.85 to prevent histamine formation and pathogenic bacteria including S. aureus and C. botulinum growth formation during and after (b)(4).

During the inspection you reported that you conduct finished product moisture content testing and the “Dried Bonito Moisture Content and Water Activity Relationship” chart from the Japanese Seafood HACCP guide dated November 2000. Our investigator reviewed your daily production report testing records in 2023 and identified a few batches intended for domestic customers with finished product moisture content levels at (b)(4)% to (b)(4)%. According to the “Dried Bonito Moisture Content and Water Activity Relationship” chart from the Japanese Seafood HACCP guide dated November 2000, a moisture content above 21% would result in Aw > 0.85. When asked about these findings, you stated that the product was retested and released after the retest results were within the moisture specification of (b)(4)%. The practice of retesting the lot is not an appropriate corrective action as it does not address the potential safety of the entire lot. Furthermore, you do not have a standardized procedure for sample collection for your moisture content testing.

In your response dated February 16, 2023, you stated you would eliminate the “(b)(4)” or (b)(4) step prior to (b)(4) cooking process. You provided your updated process flow diagram and stated the HACCP plan would be revised by April 2023. You also provided an (b)(4) study where you collected moisture data at receiving and after (b)(4) cooking steps for (b)(4) days to measure the relationship between water activity and water (moisture) content). You reported the water activity did not exceed 0.85 during the (b)(4) step. You also reported that if the moisture content exceeds (b)(4)% you would not use the product. You stated you identify the moisture test of the product as a [critical] control point. However, FDA remains concerned about your determination of a direct correlation between moisture content and water activity and using moisture content as the critical limit before and after the (b)(4) cooking steps. FDA recommends you monitor water activity rather than percent moisture.

We cannot assess the adequacy of your corrective action without your revised HACCP plan, please provide include your revised HACCP plan in your response to this letter. In addition, we are requesting five (5) consecutive days of completed monitoring records demonstrating the implementation of your revised HACCP plan. The records provided must be in English.

2. You must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), to comply with 21 CFR 123.11(b). However, you did not adequately monitor the conditions and cleanliness of food contact surfaces, as required by 21 CFR 123.11(b)(3).

Specifically, on January 25, 2023, our investigator observed the curtains on several shredding machines were stained with a black mold-like substance and the conveyor belt on one of the shredding machines was cracked and missing fiber parts. Our investigator reviewed the pre-operational and operational record dated January 24, 2023 and did not observe any sanitation issues nor disrepair on the shredding machines.

Although you promised corrections and stated you would clean and make repairs as soon as possible, you did not provide any supporting documentation that you have cleaned and repaired the shredding machines. In your response to this letter, please provide information about how you will ensure that all 8 areas of sanitation are monitored, and documented corrections are taken when warranted.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. 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 that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery 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, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://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 processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

We also offer the following comment:

Your HACCP plan is either missing multiple critical control points (CCPs) to control histamine formation or missing a critical limit at receiving to control histamine and pathogens. Your raw material’s supplier HACCP plan, provided during the inspection, does not identify what water activity the raw material must achieve and does not identify CCPs to control water activity. You have not provided sufficient scientific support for your hazard analysis to determine that histamine and pathogens are not a hazard when the raw material is exposed to unrefrigerated conditions, i.e., the incoming product is shelf stable. You may either obtain the necessary scientific support for your hazard analysis’s findings or identify processing CCPs for the (b)(4) processing steps.

You should direct your written reply to Victoria Wagoner, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. Please include reference # 658697 on any submissions and within the subject line of any emails to us. If you have any questions regarding this letter, you may contact Ms. Wagoner via email at: Victoria.Wagoner@fda.hhs.gov.

Sincerely,
/S/

Ann Oxenham, Director
Office of Compliance
Center for Food Safety and Applied Nutrition

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