Shang Hao Jia, Inc. — FDA Warning Letter, 2026-03-18: Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
At a glance: On October 28, 2025, the FDA inspected Shang Hao Jia, Inc. (South El Monte, CA) and found the importer failed to develop, maintain, or follow Foreign Supplier Verification Programs (FSVP) for foods imported from China and other locations, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. The company discontinued three products (Danshi Spicy Shredded Tofu, Rye Soda Cracker, and Almond Cake) and initiated recalls, but FDA stated it cannot evaluate adequacy of corrective actions without supporting documentation, and warned that failure to address violations may result in refusal of admission or detention without physical examination of imported foods under Import Alert #99-41.
Argus analysis
# FDA Warning Letter: Shang Hao Jia, Inc. — FSVP Violations
**Company and Findings**
Shang Hao Jia, Inc., a food importer based in South El Monte, California, received a warning letter from the FDA's Office of Inspections and Investigations on March 18, 2026, following an October 2025 inspection. The FDA found that the company failed to establish Foreign Supplier Verification Programs (FSVP) for multiple imported food products, including Danshi Spicy Shredded Tofu, Rye Soda Cracker, and Almond Cake sourced from suppliers in China. The company's Chief Executive Officer, Daniel Dinghua Chen, acknowledged discontinuing certain product lines and initiating a sesame allergen recall for tofu products after FDA notification, but did not submit documentation of corrective actions or completed FSVP plans.
**Regulatory Citations**
The violations centered on 21 CFR Part 1, Subpart L, which implements Section 805 of the Federal Food, Drug, and Cosmetic Act. This regulation requires food importers to develop, maintain, and follow risk-based verification programs demonstrating that foreign suppliers meet U.S. food safety standards. The FDA also cited 21 CFR 1.508(a), requiring documented corrective actions when suppliers fail to comply with safety or labeling requirements. These provisions form the foundation of FDA's preventive control system for imported foods under the Food Safety Modernization Act.
**Response Timeline and Outlook**
The company has 15 working days to submit a written response addressing violations and providing documentation of corrective actions. Shang Hao Jia previously requested a two-month extension to develop FSVPs, which the FDA did not approve in the letter. Peer compliance officers should monitor whether the importer submits adequate FSVP documentation and whether FDA escalates to detention without physical examination (DWPE) under Import Alert #99-41 for future shipments. Failure to respond adequately could result in refusal of admission for imported foods under Section 801(a)(3).
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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 Shang Hao Jia, Inc. MARCS-CMS 720238 — March 18, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Daniel Dinghua Chen Recipient Title Chief Executive Officer Shang Hao Jia, Inc. 2311 Merced Ave South El Monte , CA 91801 United States Issuing Office: Office of Inspections and Investigations United States March 18, 2026 WARNING LETTER Re: CMS #720238 Dear Mr. Chen: On October 28, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of Shang Hao Jia, Inc. located at 2311 Merced Ave, South El Monte, CA 91801. 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 responses dated November 13, 2025, November 14, 2025 and November 17, 2025, in which you stated you discontinued the importation of Danshi Spicy Shredded Tofu and (b)(4) imported from Sichuan Shifang Danshi Food Co. Ltd, China; Rye Soda Cracker from Zhejiang Dingdian Industry Co. Ltd, China; and Almond Cake from (b)(4) . You also indicated that you want to import food products into the U.S. and will develop FSVPs for products you import, but you need additional time to complete the FSVPs. You requested an extension of two months to complete the FSVPs. Lastly, you indicated in your response that you initiated recalls for the Danshi Spicy Shredded Tofu and Rye Soda Cracker upon notification from FDA and followed through with the recall process. 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: 1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 …
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 FDA violations was Shang Hao Jia, Inc. cited for?
- The FDA Warning Letter to Shang Hao Jia, Inc. (issuing office: Office of Inspections and Investigations) cites: Foreign Supplier Verification Program (FSVP). Classification: Warning Letter.
- When did FDA issue the warning letter to Shang Hao Jia, Inc.?
- FDA issued the letter (MARCS-CMS 720238) on 2026-03-18 and posted it publicly on fda.gov on 2026-07-21.
- Is the FDA warning letter to Shang Hao Jia, Inc. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shang-hao-jia-inc-720238-03182026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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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). Shang Hao Jia, Inc. — FDA Warning Letter, 2026-03-18: Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-shang-hao-jia-inc-2026-03-18-warning-letter
"Shang Hao Jia, Inc. — FDA Warning Letter, 2026-03-18: Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-shang-hao-jia-inc-2026-03-18-warning-letter.
Argus HQ Research. "Shang Hao Jia, Inc. — FDA Warning Letter, 2026-03-18: Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed July 22, 2026. https://argushq.ai/fda/warning-letter/fda-wl-shang-hao-jia-inc-2026-03-18-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_shang_hao_jia_inc_2026_03_18_warning_letter_2026,
title = {Shang Hao Jia, Inc. — FDA Warning Letter, 2026-03-18: Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-shang-hao-jia-inc-2026-03-18-warning-letter},
note = {Accessed: July 22, 2026}
}