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June 10, 2024

WARNING LETTER

Re: CMS #676865

Dear Mr. Kimura:

On November 6 and 13, 2023 and December 15, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of AKT Trading Inc. located at 2161 W 182nd St, Ste 102, Torrance, CA 90504. We also conducted inspections on January 26, 2018, and June 16 through August 6, 2020. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule- foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import from (b)(4): processed enoki mushrooms (also called nametake mushrooms) imported from (b)(4); processed shitake mushrooms imported from (b)(4), dried enokitake mushrooms imported from (b)(4); and prepared bamboo shoots, imported from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.

We acknowledge receipt of your responses dated December 27, 2023 and January 5, 2024, and we address your responses below.

Your significant violations of the FSVP regulation are as follows:

1. As part of your evaluation of a foreign supplier’s performance and the risk posed by a food, as required under 21 CFR 1.505(a)(1), which includes approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you did not consider the foreign supplier’s performance including the applicable FDA food safety regulations as required for an evaluation under 21 CFR 1.505(a)(1)(iii).

Based on documents provided to FDA, the prepared bamboo shoot product manufactured by (b)(4) is as an acidified food. However, your FSVP did not include documentation that you considered whether your supplier had complied with the applicable FDA food safety regulations, such as the regulations for acidified foods in 21 CFR parts 108 and 114, which may include filing with FDA a scheduled process (21 CFR part 108) to control the biological hazards identified in your hazard analysis.

Your December 27, 2023 and January 10, 2024 responses did not provide documentation of any changes to your FSVPs or describe your corrective action to consider your foreign supplier performance, including compliance with applicable FDA food safety regulations, as required under 21 CFR 1.505(a)(1)(iii).

2. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). During our inspection, you provided your FSVPs for processed enoki mushroom (also called nametake mushrooms) products from (b)(4); processed shitake mushrooms from (b)(4) and dried enokitake mushrooms from (b)(4). While the FSVP documents you provided included documentation of your approval of each supplier and a copy of your supplier’s food safety plan, you did not include documentation of your determination of the appropriate supplier verification activities or frequency with which such activities must be conducted, as required under 21 CFR 1.506(d)(1)(i).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place prepared bamboo shoot products, processed enoki mushroom products, processed shitake mushroom products, and dried enokitake mushroom products imported from foreign suppliers (b)(4) on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

Additionally, we offer the following comments:

We acknowledge you provided audit reports performed by (b)(4) on December 27 and 28, 2023, respectively, for (b)(4) imported from (b)(4) and seasoned bamboo shoots (b)(4) imported from (b)(4). You should ensure that you promptly review and assess the third-party audits, as well as document your review and assessment, as required by 21 CFR 1.506(e). Additionally, since you have chosen to conduct onsite audits as your verification activities for preserved bamboo shoots imported from (b)(4); and prepared miso paste imported from (b)(4), you should modify your FSVPs to reflect this change.

During our inspection you told our investigator that your products imported (b)(4) were shipped refrigerated, and provided shipping documents that indicated the products were shipped refrigerated. Your FSVP for prepared bamboo shoots from (b)(4) included product specifications that described the storage and distribution for the products as “cold storage (below (b)(4)C).” However, the hazard analyses you provided do not describe a requirement for refrigeration to control any hazards in this product. Specifically, neither your hazard analysis nor your foreign supplier’s hazard analysis indicated refrigeration as a control for biological hazards. If you determine refrigeration is an appropriate control for a hazard in food you import, for example, to control biological hazards related to storage and distribution, then you will need to conduct verification activities to provide assurance that the hazard is being significantly minimized or prevented by the foreign supplier or other responsible entity (21 CFR 1.506(c).

In your written response dated December 27, 2023, you provided a letter in which you stated that you discontinued importation of processed enoki mushrooms from (b)(4). You also stated the reason for discontinuation as being due to a shipment being detained on “2/24/2023” and because the product was on Import Alert #99-37. We note that if you resume importing food from this foreign supplier, under 21 CFR 1.505(c), you must promptly reevaluate the concerns associated with the foreign supplier’s performance, including applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety. You must document any investigations, corrective actions, and changes to your FSVP that you undertake (21 CFR 1.508(b)).

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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.

Please send your reply to Food and Drug Administration, Attention: Lydia S. Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Lydia Chan via email at lydia.chan@fda.hhs.gov. Please reference CMS #676865 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports