2026-06-26 FDA Warning Letter: Shouly Import Corp. Cited for Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
In short: The FDA issued a warning letter to Shouly Import Corp. (CMS# 731741) on June 26, 2026, following an April 30, 2026 inspection, citing failure to develop and maintain a Foreign Supplier Verification Program (FSVP) as required by section 805 of the FD&C Act and 21 CFR part 1, subpart L for imported foods including roasted white sesame, feta cheese, and baklava. The company must respond within 15 working days with documentation of corrective actions; the FDA may refuse admission of imported foods or place them on detention without physical examination if violations are not adequately addressed.
Argus analysis
# FDA Warning Letter Analysis: Shouly Import Corp.
**Company and Findings**
Shouly Import Corp., a food importer based in Clifton, New Jersey, received a warning letter from the FDA's Office of Inspections and Investigations on June 26, 2026, following an April 30, 2026 inspection. The agency determined that the company failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for imported food products, including roasted white sesame, feta cheese, and baklava. The inspection revealed systemic gaps in supplier verification documentation and risk-based controls required for imported foods.
**Regulatory Citations and Context**
The violations cited 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 develop written programs verifying that suppliers meet U.S. food safety standards before products enter commerce. Specifically, 21 CFR 1.502(a) requires development and implementation of an FSVP for each imported food. The company's failure to create product-specific verification plans for any of its imported items represents a foundational compliance gap that exposes the FDA to potential safety risks in the food supply chain.
**Response Timeline and Industry Observations**
Shouly Import Corp. submitted an initial response on May 13, 2026, committing to six-month completion of full FSVP implementation with consultant assistance. However, the FDA stated it could not evaluate adequacy due to lack of supporting documentation. The company faces a 15 working-day deadline to provide detailed corrective action evidence. Peer compliance officers should monitor whether the company provides substantive FSVP documentation, as failure to respond adequately may trigger detention without physical examination (DWPE) of imported products under Import Alert 99-41 or refusal of admission under Section 801(a)(3).
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 Shouly Import Corp. MARCS-CMS 731741 — June 26, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Mohammad Shouly Recipient Title Partner/Owner Shouly Import Corp. 371 Lakeview Ave Clifton , NJ 07011-4037 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States June 26, 2026 WARNING LETTER RE: CMS# 731741 Dear Mr. Mohammad Shouly: On April 30, 2026 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Shouly Import Corp., 371 Lakeview Ave, Clifton, NJ 07011-4037. 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-modernization-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 May 13, 2026, in which you stated Shouly Import Corp has engaged a qualified FSVP consultant and initiated corrective actions, including reviewing all imported products and suppliers, developing product-specific FSVP documentation, collecting supplier food safety records, implementing written procedures, and establishing ongoing verification activities. Due to the scope of the work, the company expects to complete full FSVP implementation for all imported products within six months and is committed to maintaining compliance with FDA requirements going forward. 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 part 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods: Roasted White Sesame imported from (b)(4) , located in…
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
- Is the FDA warning letter to Shouly Import Corp. 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/shouly-import-corp-731741-06262026.
- 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.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
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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). 2026-06-26 FDA Warning Letter: Shouly Import Corp. Cited for Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-shouly-import-corp-2026-06-26-warning-letter
"2026-06-26 FDA Warning Letter: Shouly Import Corp. Cited for Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-shouly-import-corp-2026-06-26-warning-letter.
Argus HQ Research. "2026-06-26 FDA Warning Letter: Shouly Import Corp. Cited for Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-shouly-import-corp-2026-06-26-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_shouly_import_corp_2026_06_26_warning_letter_2026,
title = {2026-06-26 FDA Warning Letter: Shouly Import Corp. 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-shouly-import-corp-2026-06-26-warning-letter},
note = {Accessed: September 23, 2026}
}