Trangs Group USA Incorporated

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02/24/2026

WARNING LETTER

Re: CMS # 723838

Dear Mr. Ho:

From January 13, 2026, through January 26, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Trangs Group USA Incorporated located at 12881 Knott St Ste 219, Garden Grove, CA 92841-3942. 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 United States 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-supplierverification-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 February 2, 2026, and February 5, 2026, in which you stated that you have responded to all necessary requirements to be FSVP compliant and that no other action is required by you. You also provided the following documents: Trangs Group USA FSVP SOP, Trangs Group USA Corrective Action Procedure, BRCGS Food Safety Certificate for (b)(4), IFS Certificate for (b)(4) HACCP plan for Frozen Steamed/Fried Bao Bun with Mixture Prawn and Vegetable Filling, BRCGS Food Safety Certificate for (b)(4), IFS Certificate for (b)(4), (b)(4) HACCP Plan for Frozen Steamed/Fried Bao Bun with Vegetables Filling, and additional HACCP plans for frozen shrimp-based products that are exempt from FSVP requirements. However, the documents provided do not indicate how they are relevant to the Frozen Bao Mini Mushroom Teriyaki Bun covered during the inspection, and you did not explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

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 the following foods:

• Frozen Bao Mini Mushroom Teriyaki Bun, imported from (b)(4), located in (b)(4).
• Frozen Bao Mini Mushroom Teriyaki Bun, 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)).

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: Celena Ngo, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 723838 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