2026-07-15 FDA Warning Letter: LDNN Produce Inc. Cited for Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
The short version: The FDA issued a warning letter to LDNN Produce Inc. (President Kaiguang Liu, Bayside, NY) on July 15, 2026, following an FSVP inspection conducted May 18-27, 2026, citing failure to develop, maintain, and follow a Foreign Supplier Verification Program for imported mushrooms and fresh yams as required by 21 CFR part 1, subpart L and section 805 of the FD&C Act. The company's June 5, 2026 response claiming records were maintained off-site in non-English format was deemed insufficient without supporting documentation of corrective actions; the FDA requests a substantive written response within 15 working days and warns that failure to comply may result in detention without physical examination or refusal of admission for imported foods.
Argus analysis
# FDA Warning Letter Analysis: LDNN Produce Inc.
**Company and Findings**
LDNN Produce Inc., a produce importer based in Bayside, New York, received a warning letter from the FDA's Office of Inspections and Investigations on July 15, 2026, following a Foreign Supplier Verification Program (FSVP) inspection conducted May 18–27, 2026. The agency found that the company failed to develop, maintain, and follow an FSVP for imported foods, specifically mushrooms from two unnamed suppliers and fresh yams from another. The inspection revealed no FSVP documentation existed for any of the company's imported products.
**Regulatory Citations and Meaning**
The violations center on 21 CFR Part 1, Subpart L (the FSVP regulation) and Section 805 of the Federal Food, Drug, and Cosmetic Act. These requirements mandate that importers conduct risk-based activities to verify that foreign suppliers produce food meeting U.S. safety standards. The letter notes that fresh produce imported by LDNN may qualify as "covered produce" under 21 CFR 112, triggering additional obligations to ensure suppliers comply with the Produce Safety Rule (21 CFR Part 112). The company's response—indicating FSVP records existed but were maintained in a non-English format at another location—did not satisfy FDA concerns without supporting documentation of corrective action.
**Response Timeline and Industry Observations**
LDNN has 15 working days from receipt to submit a written response addressing specific corrections. Peer compliance officers in produce importing should monitor whether the company develops a documented FSVP and submits evidence of supplier verification activities. The FDA signaled potential escalation to detention without physical examination (DWPE) status under Import Alert #99-41 or refusal of entry under Section 801(a)(3), outcomes that would affect industry-wide import patterns and competitor positioning.
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 LDNN Produce Inc. MARCS-CMS 732492 — July 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Kaiguang Liu Recipient Title President LDNN Produce Inc. 5307 206th Street Bayside , NY 11364-1713 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States July 15, 2026 WARNING LETTER RE: CMS# 732492 Dear Mr. Kaiguang Liu: On May 18 through May 27, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of LDNN PRODUCE INC., located at 5307 206th St., Bayside, NY 11364-1713. 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-moderniza tion-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 response, dated June 5, 2026, in which you stated that your FSVP records are not maintained in English, but could be provided in English within 2–3 weeks upon request, and are maintained at another location. You also provided contact information, including a phone number with office hours and an address where the FSVP records are said to be maintained. 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: Mushrooms imported from (b)(4) , located in (b)(4) . Mushrooms imported from (b)(4) , located in (b)(4) . Fresh Yams imported from (b)(4) , located in (b)(4) . You import fresh produce that may be considered “covered produce” as defined in 21 CFR 112.3. If after review of the fresh produce that you impor…
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 LDNN Produce Inc.?
- FDA issued the letter (MARCS-CMS 732492) on 2026-07-15 and posted it publicly on fda.gov on 2026-09-22.
- Is the FDA warning letter to LDNN Produce 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/ldnn-produce-inc-732492-07152026.
- 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). 2026-07-15 FDA Warning Letter: LDNN Produce Inc. Cited for Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ldnn-produce-inc-2026-07-15-warning-letter
"2026-07-15 FDA Warning Letter: LDNN Produce Inc. Cited for Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ldnn-produce-inc-2026-07-15-warning-letter.
Argus HQ Research. "2026-07-15 FDA Warning Letter: LDNN Produce Inc. Cited for Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ldnn-produce-inc-2026-07-15-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ldnn_produce_inc_2026_07_15_warning_letter_2026,
title = {2026-07-15 FDA Warning Letter: LDNN Produce Inc. Cited for 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-ldnn-produce-inc-2026-07-15-warning-letter},
note = {Accessed: September 23, 2026}
}