YS Group Inc. — FDA Warning Letter, June 8, 2026: Foreign Supplier Verification Program (FSVP)

FDA Warning Letter — Violations FDA cited at YS Group Inc.

WARNING LETTER YS Group Inc. MARCS-CMS 731129 — June 08, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 insta