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  5. Shang Hao Jia, Inc. - 720238 - 03/18/2026
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WARNING LETTER

Shang Hao Jia, Inc. MARCS-CMS 720238 —

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 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:

  • Danshi Spicy Shredded Tofu imported from Sichuan Shifang Danshi Food Co. Ltd, located in China
  • (b)(4) imported from Sichuan Shifang Danshi Food Co. Ltd, located in China
  • Rye Soda Cracker imported from Zhejiang Dingdian Industry Co. Ltd, located in China
  • Almond Cake imported from (b)(4), located in (b)(4)

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 foods you import into the United States 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)).

In addition, we offer the following comments:
21 CFR 1.508(a) requires that you must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act and the implementing regulations, or produces food that is adulterated under section 402 of the FD&C Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the foreign supplier verification activities conducted under 21 CFR 1.506 or 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under 21 CFR 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include notifying the foreign supplier of the problem and requesting documentation of corrective actions taken by the foreign supplier or discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with 21 CFR 1.508(a).

You initiated a recall of Danshi Spicy Shredded Tofu imported from Sichuan Shifang Danshi Food Co. Ltd, located in China on June 25, 2025, after you were notified of the undeclared allergen (sesame) on the product label. During our inspection, you told our investigator that you spoke to your foreign supplier about the labeling issue and ceased importation of products from the foreign supplier. The activities you described at the inspection may be part of corrective actions, pursuant to 21 CFR 1.508. You are required to document any corrective actions you take in accordance with 21 CFR 1.508(a).

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 #720238 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

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