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  5. Miyajima Shoyu Co., Ltd. - 689638 - 09/30/2024
  1. Warning Letters

WARNING LETTER

Miyajima Shoyu Co., Ltd. MARCS-CMS 689638 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Satoru Iwamoto
Recipient Title
Head of Myoken Factory
Miyajima Shoyu Co., Ltd.

1-18 Nakanosedor
Karatsu, Saga
847-0101
Japan

iwamoto@miyajima-soy.co.jp
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

WARNING LETTER

Reference No. 689638

Dear Mr. Iwamoto:

The United States Food and Drug Administration (FDA) inspected your acidified food facility located at 1-18, Nakanosedor, Karatsu, Saga, Japan 847-0101 on May 24 through May 27, 2024. 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 Part 108) and the Acidified Foods regulation (21 CFR Part 114). 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 received your written response dated June 12, 2024. Our evaluation found your response was not adequate, as further described in this letter.

As a manufacturer of acidified foods intended for export to the United States (U.S.), you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of acidified food products 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 acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration, and filing of process information, and the mandatory requirements in 21 CFR Part 114.

Regulations specific to the processing of acidified foods are described in 21 CFR Part 108 and 21 CFR Part 114. As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 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 108.25(j) 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. Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 renders your acidified food 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 acidified food regulations through links in FDA’s home page at www.fda.gov.

Your significant violation is as follows:

As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). At this time, none of your firm’s acidified food scheduled processes have been filed with FDA, including your acidified Wasabi Dressing shipped to the U.S. Scheduled process information for acidified foods must be submitted on Form FDA 2541e Food Process Filing for Acidified Method. Specifically, you manufacture ready-to-eat, shelf stable acidified dressings, including acidified (Taradake no) Wasabi Dressing shipped to the U.S.; however, you have not filed a scheduled process for your acidified Wasabi Dressing.

In addition, you did not provide evidence to FDA that your scheduled process for your acidified (Taradake no) Wasabi Dressing was established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods, as required by 21 CFR 114.83. Nevertheless, you have established a food safety plan which identifies known or reasonably foreseeable hazards requiring preventive controls and identifies controls for the respective hazards at those processing steps. Along with controls for the hazards for allergens and metal, you have identified a controls and parameters at the following steps for their respective hazards: cook temperature of (b)(4) °C at the ‘(b)(4)’ step to control for vegetative pathogens in raw materials; temperature of (b)(4) °C at the ‘(b)(4)’ step to control for vegetative pathogens on finished product container; and (b)(4) at ‘(b)(4)’ step to control for Clostridium botulinum (C. bot). However, a review of your manufacturing record for acidified (Taradake no) Wasabi Dressing dated December 15, 2022, indicates some of your pH values for the batch are over 4.5. We recommend you have any acidified Wasabi Dressing shipped to the U.S. with a pH > 4.6 evaluated by a qualified person to determine if there is a health risk associated with the product and act accordingly to protect public health. Please include your evaluation in your response to this Warning Letter.

Furthermore, you have identified a temperature control at the ‘(b)(4)’ step and described the filling of the acidified Wasabi Dressing. You stated before capping the bottle that you add (b)(4) ml ambient temperature oil to approximately (b)(4) ml of the dressing base after approximately (b)(4) seconds. No additional heat treatment is applied to the product before the bottles are capped, sealed, and labeled. The addition of an ambient ingredient at the (b)(4) step may likely lower the temperature of the product to less than (b)(4) °C. This temperature may not be an effective (b)(4) step. In your response to this letter, you should address this process and determine if there is a health risk associated with your filling process and temperature.

Lastly, our investigator reviewed finished product microbiological and organoleptic analyses associated with each batch of final product and did not identify any significant deficiencies. However, according to your description of the process, you collect the sample of the dressing base for pH, Brix, salinity, prior to filling to ensure that the product meets specifications. You must ensure that you are correctly measuring the finished equilibrium pH of the acidified Wasabi Dressing to ensure it is less than 4.6 and does not exceed the maximum equilibrium pH value as determined by a qualified person with expert knowledge as described above.

Your response stated you understand your acidified Wasabi Dressing is an acidified food and you notified your domestic distributors and employees. You also added that you have decided to not export the product to the U.S. and provided a copy of the letter you shared with your customers requesting they suspend exportation of the product to the U.S. During the inspection, you told our investigator that you do not export directly to the U.S. but rather you sell your products to domestic trading companies who export your products to the U.S. Acidified foods shipped to the U.S. without a filed scheduled process and not in compliance with the mandatory requirements listed in 21 CFR Part 114, as described in 21 CFR 108.25, are considered adulterated.

Your response also stated (b)(4).” You stated (b)(4). You must have your scheduled process established by a qualified person, as required by 21 CFR 114.83. In your response to this Warning Letter, you should provide the information regarding the qualified person who is collecting the scientific data to support your scheduled process if you intend to export acidified foods to the U.S.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, 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 acidified food 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 acidified food regulations (21 CFR Parts 108 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 you operate in compliance with the Act and all applicable FDA regulations, including Acidified Foods regulation (21 CFR Part 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). For example, if you do resume exportation of acidified foods to the U.S. you must ensure you have adequate controls in place to ensure finished equilibrium pH < 4.6 and each container bears an identifying code to specify the establishment where the product was packed and the product contained within (21 CFR 114.80(a) and (b). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. 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: although you have requested that your customers “suspend” exportation of your product to the United States, FDA is aware of situations where adulterated foods manufactured in another country may be shipped to the U.S., in some cases without the manufacturer’s knowledge, often referred to as the “gray market.” Section 801(m)(1) (21 U.S.C. 381(m)(1) of the Act states that prior notice must be submitted for the article of food, and it must contain the identity of the manufacturer of the food being imported or offered for import. Accordingly, the automated commercial environment (ACE) U.S. Customs broker (filer) must submit at the time of entry filing for an acidified food, the Food Canning Establishment Number (FCE) and the Submission Identifier (scheduled process number) and can dimensions or volume, as required by 21 CFR 1.73(c). We recommend that you inform your customers that your acidified food products do not have scheduled processes that have been filed with FDA, so there is no scheduled process number that can be provided for prior notice. If you decide to resume exports to the U.S., we recommend you share your FCE and scheduled process numbers with your customers to ensure that they properly file prior notice with FDA. A failure to properly file an acidified food offered for import to the U.S. may result in the detention and refusal of the acidified food and the addition of the acidified food and the manufacturer to be placed on Import Alert #99-37.

Please send your reply to the Food and Drug Administration via email to Victoria.Wagoner@fda.hhs.gov. If sending a response by mail address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Victoria Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference 689638 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
  and Applied Nutrition

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