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WARNING LETTER

Great Enterprise - Group - Inc. MARCS-CMS 727852 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Phat V. Phung
Recipient Title
President
Great Enterprise - Group - Inc.

2660 Waiwai Loop
Honolulu, HI 96819-1992
United States

(b)(6), (b)(7)(C)
Issuing Office:
Office of Inspections and Investigations

United States

April 17, 2026

WARNING LETTER

Re: CMS # 727852

Dear Mr. Phung:

On April 2, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Great Enterprise (Group) Inc., located at 2660 Waiwai Loop, Honolulu, HI 96819-1992. We also conducted inspections on April 11 and 24, 2019; January 28 through February 10, 2021; and July 24, 2023. These inspections were 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-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent 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 April 15, 2026, in which you stated that you have initiated steps to develop an FSVP program by requesting hazard analysis documents from your suppliers and exploring training options. You also committed to establishing a comprehensive FSVP program and achieving full compliance by your next inspection. 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:

  • (b)(4) Hoisin Sauce imported from (b)(4), located in (b)(4).
  • Canned Bamboo Shoots Slices imported from (b)(4), located in (b)(4).
  • (b)(4) Rice Stick imported from (b)(4), located in (b)(4).
  • Rice Stick imported from (b)(4), located in (b)(4).
  • (b)(4) Rice Stick imported from (b)(4), located in (b)(4).

During our inspection you provided the investigator with the following documents: copies of product labels, invoices, Entry Summaries, Certificates of Analysis, a Certificate of Ingredients, a flow chart, a HACCP plan, and third-party food safety certifications including (b)(4). You told our investigator that you requested these documents from your foreign suppliers. However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or 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).

For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). However, you did not verify and document that the canned food products you import, including but not limited to Canned Bamboo Shoots Slices imported from (b)(4), located in (b)(4) were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).

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, or wish to send your response electronically, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 727852 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

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