Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Moda Food LLC, 2026-09-09
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
Here's the summary: On March 13-18, 2026, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Moda Food LLC (Woodland Park, NJ) under 21 CFR part 1, subpart L, following prior inspections in December 2022, December 2023, and June 2024. The FDA found the company failed to develop and maintain required FSVPs for imported foods including Phyllo, Baklava (Double Pistachio), and Tahini Halva; claimed some imports were for research/evaluation but provided no documentation meeting exemption criteria under 21 CFR 1.501(c); and failed to determine, document, and conduct adequate supplier verification activities with required frequency or retain supporting documentation per 21 CFR 1.506.
Argus analysis
# FDA Warning Letter Analysis: Moda Food LLC
**Company and Findings**
Moda Food LLC, a food importer based in Woodland Park, New Jersey, received a warning letter dated September 9, 2026, from the FDA's Office of Inspections and Investigations. During a Foreign Supplier Verification Program (FSVP) inspection conducted March 13–18, 2026—following prior inspections in December 2022, December 2023, and June 2024—the FDA identified significant compliance failures. The company failed to establish adequate verification procedures for imported phyllo, baklava, tahini halva, and products from other foreign suppliers on an attached list.
**Regulatory Citations and Implications**
The violations centered on 21 CFR Part 1, Subpart L (the FSVP regulation), which implements Section 805 of the Federal Food, Drug, and Cosmetic Act. Specifically, Moda Food failed to comply with 21 CFR 1.502(a) by not developing FSVPs for certain imports, and 21 CFR 1.506 by not determining, documenting, or conducting required supplier verification activities. The company also improperly claimed exemptions under 21 CFR 1.501(c) for research-and-development products without proper documentation or proof that quantities were consistent with such use. These requirements mandate importers maintain documented evidence of supplier audits, certifications review, or food safety record assessments conducted by qualified personnel.
**Response Timeline and Monitoring Points**
Moda Food has 15 working days from letter receipt to submit a written corrective action plan to the Division of Northeast Imports. Compliance officers in the food import sector should watch for whether the company obtains detention-without-physical-examination (DWPE) status for future shipments under Import Alert #99-41, which signals elevated FDA scrutiny. Additional enforcement actions—including refusal of admission under Section 801(a)(3)—remain possible if the company does not adequately address violations.
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 Moda Food LLC MARCS-CMS 727800 — September 09, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery and Electronic Mail Product: Food & Beverages Recipient: Recipient Name Rubil Vural Recipient Title Owner Moda Food LLC 4 Andrews Dr Woodland Park , NJ 07424 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States WARNING LETTER Re: CMS # 727800 Dear Mr. Rubil Vural, On March 13 through 18, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Moda Food LLC, located at 4 Andrews Dr, Woodland Park, NJ 07424. We also conducted inspections on December 29, 2022, December 6, 2023, and June 12, 2024. 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 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 most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list, as well as your Phyllo imported from (b)(4) , your Baklava (Double Pistachio) imported from (b)(4) , and your Tahini Halva imported from (b)(4) , all located in (b)(4) . 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 have not received your response to the Form FDA 483a issued on March 18, 2026. 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 part 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list. During the inspection, you stated that the foods for which you had no FSVPs were samples for food shows and for research and development. Pursuant to 21 CFR 1.501(c), food imported for research or evaluation is exempt from the FSVP requirements provided that it is: (1) not intended for retail sale and is not sold or distributed to the public, (2) labeled with the statement “Food for research or evaluation use,” (3) imported in a small quantity that is consist…
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 Moda Food LLC?
- FDA issued the letter (MARCS-CMS 727800) on 2026-09-09 and posted it publicly on fda.gov on 2026-10-13.
- Is the FDA warning letter to Moda Food LLC 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/moda-food-llc-727800-09092026.
- 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 Moda Food LLC, 2026-09-09. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-moda-food-llc-2026-09-09-warning-letter
"Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Moda Food LLC, 2026-09-09." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-moda-food-llc-2026-09-09-warning-letter.
Argus HQ Research. "Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Moda Food LLC, 2026-09-09." Digital Empire Holdings LLC. Accessed October 14, 2026. https://argushq.ai/fda/warning-letter/fda-wl-moda-food-llc-2026-09-09-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_moda_food_llc_2026_09_09_warning_letter_2026,
title = {Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Moda Food LLC, 2026-09-09},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-moda-food-llc-2026-09-09-warning-letter},
note = {Accessed: October 14, 2026}
}