1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. YS Group Inc. - 731129 - 06/08/2026
  1. Warning Letters

WARNING LETTER

YS Group Inc. MARCS-CMS 731129 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Yamato Miura, Co-Chief Executive Officer and Chief Financial Officer
Recipient Title
Steve Tieu, Co-Chief Executive Officer and Secretary
YS Group Inc.

1108 S Baldwin Ave Suite B6
Arcadia, CA 91007
United States

Issuing Office:
Office of Inspections and Investigations

United States

June 8, 2026

WARNING LETTER

Re: CMS #731129

Dear Mr. Miura and Mr. Tieu:

On April 30, 2026 through May 12, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of YS Group Inc. located at 1108 S Baldwin Ave Suite B6, Arcadia, CA 91007. This inspection was 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import.

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 response dated June 2, 2026 in which you stated you developed the hazard analysis for the tofu skin imported from (b)(4) and requested (b)(4) to provide a certificate of analysis for future shipments of tofu skin as documentation of your verification activity. You also clarified that the foreign supplier of the buckwheat flour listed on the Form FDA 483a was a distributor and you will update your database to the correct manufacturer. You included the hazard analysis for tofu skin imported from (b)(4) with the response. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:

  • Tofu Skin imported from (b)(4)
  • Dried Seaweed imported from (b)(4)
  • Buckwheat Flour imported from (b)(4)

During our inspection you provided the following:

  • Supplier HACCP Verification Records for (b)(4), and (b)(4)
  • HACCP plan for (b)(4)

You stated that you are not familiar with FSVP requirements and have just recently started to conduct and document FSVP activities. However, it is not clear how these documents would apply to your FSVP program as the HACCP records are for fish and fishery products, and you did not explain how they would apply to your FSVP program.

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 the food from the identified foreign supplier 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)).

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 any 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 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 you 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 working 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 Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Lydia Chan via email at lydia.chan@fda.hhs.gov. Please reference CMS #731129 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

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

Back to Top