FDA Warning Letter to YS Group Inc. (2026-06-08) — Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
Key takeaway: FDA's Office of Inspections and Investigations issued a Warning Letter to YS Group Inc. on 2026-06-08 regarding Foreign Supplier Verification Program (FSVP). The letter references 21 CFR 1.502(a). The verbatim letter is published on fda.gov.
Argus analysis
YS Group Inc. received a Warning Letter from FDA's Office of Inspections and Investigations, dated 2026-06-08, regarding Foreign Supplier Verification Program (FSVP). The letter follows an FDA inspection and is classified by Argus HQ as low severity, consistent with the matters detailed in the letter body below.
The published letter cites 21 CFR 1.502(a). Warning Letters citing these sections generally concern the matters detailed in the letter body below. The full citation language and supporting observations are in the verbatim letter linked below — Argus HQ does not add citations beyond what FDA published.
FDA Warning Letters carry a 15-business-day response window for the recipient to detail corrective actions. Peer compliance teams in the same product category typically use a letter like this one as an external audit trigger, checking whether their own quality system has documented coverage for the cited sections and whether their CAPA log would withstand the same line of inspection questioning.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has YS Group Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for YS Group Inc. as of 2026-06-16. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Warning Letter to YS Group Inc. (2026-06-08) — Foreign Supplier Verification Program (FSVP). Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ys-group-inc-2026-06-08-warning-letter
"FDA Warning Letter to YS Group Inc. (2026-06-08) — Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ys-group-inc-2026-06-08-warning-letter.
Argus HQ Research. "FDA Warning Letter to YS Group Inc. (2026-06-08) — Foreign Supplier Verification Program (FSVP)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ys-group-inc-2026-06-08-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ys_group_inc_2026_06_08_warning_letter_2026,
title = {FDA Warning Letter to YS Group Inc. (2026-06-08) — Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ys-group-inc-2026-06-08-warning-letter},
note = {Accessed: July 13, 2026}
}