Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Great Enterprise - Group - Inc., 2026-04-17
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
At a glance: FDA issued a Warning Letter to Great Enterprise - Group - Inc. on 2026-04-17 citing: Foreign Supplier Verification Program (FSVP). Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/great-enterprise-727852-group
Argus analysis
Great Enterprise - Group - Inc. (MARCS-CMS 727852) received an FDA Warning Letter dated April 17, 2026 from the Office of Inspections and Investigations. The letter cites: Foreign Supplier Verification Program (FSVP). FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 23, 2026.
FSVP letters cite 21 CFR Part 1, Subpart L, which requires food importers to verify that their foreign suppliers produce food meeting US safety standards. Common findings include no FSVP on file, an FSVP that fails to include a hazard analysis, or one not signed and dated by a qualified individual — omissions FDA treats as an importer-level compliance gap independent of the foreign facility's own record.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
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 Great Enterprise - Group - Inc. MARCS-CMS 727852 — April 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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) …
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
- When did FDA issue the warning letter to Great Enterprise - Group - Inc.?
- FDA issued the letter (MARCS-CMS 727852) on 2026-04-17 and posted it publicly on fda.gov on 2026-06-23.
- Is the FDA warning letter to Great Enterprise - Group - 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/great-enterprise-727852-group.
- 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.
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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). Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Great Enterprise - Group - Inc., 2026-04-17. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-great-enterprise-group-inc-2026-04-17-warning-letter
"Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Great Enterprise - Group - Inc., 2026-04-17." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-great-enterprise-group-inc-2026-04-17-warning-letter.
Argus HQ Research. "Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Great Enterprise - Group - Inc., 2026-04-17." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-great-enterprise-group-inc-2026-04-17-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_great_enterprise_group_inc_2026_04_17_warning_letter_2026,
title = {Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Great Enterprise - Group - Inc., 2026-04-17},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-great-enterprise-group-inc-2026-04-17-warning-letter},
note = {Accessed: July 13, 2026}
}