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  5. Maruhachi Muramatsu Inc., Danchi Factory - 694274 - 10/17/2024
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WARNING LETTER

Maruhachi Muramatsu Inc., Danchi Factory MARCS-CMS 694274 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Masahito Kawamura
Recipient Title
Managing Director
Maruhachi Muramatsu Inc., Danchi Factory

1281-8 Souemon
Yaizu, Shizuoka
425-0065
Japan

masahito.kawamura@08m.co.jp
Issuing Office:
Human Foods Program

United States

October 17, 2024

Warning Letter

Re: CMS #694274

Dear Mr. Masahito Kawamura :

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Maruhachi Muramatsu Inc., Danchi Factory, located at 1281-8 Souemon, Yaizu, Shizuoka, 425-0065, Japan on April 23 and 24, 2024. During the inspection, we found that you had serious violations of the seafood HACCP regulation (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. We acknowledge receipt of your response via email on May 10, 2024. Your response included your revised HACCP plan for Noko Dashi Katsuo Maruhachi BR, dated May 10, 2024, as evidence of your corrective actions. 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 refrigerated reduced oxygen packaged (ROP) soup Noko Dashi Katsuo (skipjack tuna extract soup base) product is 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 the June 2022 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.

Your significant deviations are as follows:

1. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. However, your firm’s HACCP plan for refrigerated, reduced oxygen packaged (ROP), Noko Dashi Katsuo soup base, issued on May 10, 2024, lists critical limits at the following critical control points (CCPs) that are not adequate.

a. At the “(b)(4)” CCP the critical limit of “(b)(4)” is not adequate to control for the hazard of vegetative pathogen survival through thermal processing. The critical limits should list the critical factors as established by a scientific validation study (e.g., flow rate, final product temperature, hold time, exposure time, initial product temperature, equipment temperature setting, etc.) that are necessary to achieve a minimum six log reduction of non-proteolytic Clostridium botulinum type B (e.g., F value =4.0 or higher which equates to 135°C for 15 seconds). For additional information, see Chapter 16 of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide)

b. At the “(b)(4)” CCP the critical limit of “(b)(4)” is not adequate to control growth and toxin formation by spore-forming pathogens (e.g., proteolytic C. botulinum and Bacillus cereus) that can survive the thermal process. The critical limits should state that the product be cooled from 57.2⁰C to 21.1⁰C (135°F to 70°F) within two hours and from 21.1⁰C to 4.4⁰C (70°F to 40°F) within an additional four hours. This CCP for cooling would not be necessary if you have evidence such as a scientific validation study that demonstrates your thermal sterilization process eliminates spore-forming pathogens of concern.

If your firm provides evidence that the refrigerated, ROP, Noko Dashi Katsuo soup base product is shelf-stable because it receives a thermal sterilization process achieving commercial sterility and the refrigeration of the finished product is not needed to control proteolytic C. botulinum, then your product may be regulated under 21 CFR 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers and obtain a scheduled process for aseptic processing and packaging.

2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3 (b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for refrigerated, ROP, Noko Dashi Katsuo soup base issued on May 10, 2024, does not list the following critical control points (CCPs).

a. The processing step of (b)(4) filling the thermally processed soup into ROP bags to prevent recontamination of the soup with pathogens including non-proteolytic C. botulinum. Since your product is thermally treated to eliminate nonproteolytic C. botulinum and filled into the final container using an enclosed continuous system, your HACCP plan should list a (b)(4)-filling CCP with a critical limit that ensures (b)(4) filling of the soup at a product temperature of 85°C (185°F) as the product enters the final container. For additional information, see Chapter 18 of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide)

b. The processing step of (b)(4) of finished product to control pathogen growth and toxin formation including proteolytic C. botulinum. Your HACCP plan should list a finished product (b)(4) CCP with a critical limit for maintaining the ambient cooler temperatures of (b)(4)°C ((b)(4)°F) or below and monitoring the ambient temperature continuously with at least a daily visual check of the recorded data. For additional information, see Chapters 12 and 13 of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide)

3. You must have a HACCP plan that at a minimum, list monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for refrigerated, ROP, Noko Dashi Katsuo soup base issued on May 10, 2024, lists a monitoring procedure frequency of “(b)(4)” at the “(b)(4)” CCP that is not adequate to control for the hazard of undeclared allergens. This monitoring should be done at least every two hours or when new labels are used in addition to before manufacturing. For additional information, see Chapter 19 of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide)

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7 (b). Corrective actions are to ensure that no adulterated product enters commerce and to ensure the cause of the deviation is corrected to prevent recurrence. However, your firm’s HACCP plan for refrigerated, ROP, Noko Dashi Katsuo soup base issued on May 10, 2024, lists corrective actions at the following CCPs that are not adequate.

a. At the “(b)(4)” CCP the corrective actions of “(b)(4)” are not adequate to control for the hazard of vegetative pathogen survival through thermal processing. The corrective actions should additionally include identifying and correcting the cause of the deviation such as repairing or adjusting the thermal processing equipment.

b. At the “(b)(4)” CCP the corrective actions of “(b)(4)” is not adequate to prevent growth and toxin formation of spore-forming pathogen that can survive the thermal process. Microbial testing is not appropriate as a corrective action. An adequate corrective action includes discarding the affected product and identifying and correcting the cause of the deviation, such as repairing or adjusting the cooler.

c. At the “(b)(4)” CCP the corrective actions of “(b)(4)” is not adequate to control for the hazard of undeclared allergens. Adequate corrective actions should include identifying and correcting the cause of the deviation such as removing inaccurate labels from processing area and discontinuing use of supplier until corrections are made.

For additional guidance of the identified food safety hazards, you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 Edition at https://www.fda.gov/media/80637/download, Chapter 2 for Conducting a Hazard Analysis and Developing a HACCP Plan, Chapter 12 Pathogenic Bacteria Growth and Toxin Formation (Other than Clostridium botulinum) as a Result of Time and Temperature Abuse, Chapter 13 for Clostridium botulinum Toxin Formation, Chapter 16 for Pathogenic Bacteria Survival Through Cooking or Pasteurization, Chapter 18 for Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes, Chapter 19 for Undeclared Major Food Allergens.

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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your Hazard Analysis and HACCP plan for your refrigerated, ROP, Noko Dashi Katsuo soup base product, 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. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct or implement corrections to the violations cited in this letter. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123) and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Giselle Jordan, Compliance Officer, Office of Compliance & Enforcement, Office of Enforcement, Division of Produce & Imports Enforcement, Imports Enforcement Branch, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Giselle Jordan via email at: giselle.jordan@fda.hhs.gov. Please include reference #694274 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/
Amy Barringer
Acting Director, Office of Enforcement
Office of Compliance & Enforcement
Human Foods Program

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