FDA Cites SL Follen Company in 2026-06-02 Warning Letter — Foreign Supplier Verification Program (FSVP)
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 SL Follen Company on 2026-06-02 citing: Foreign Supplier Verification Program (FSVP). Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sl-follen-company-730191-06022026
Argus analysis
SL Follen Company (MARCS-CMS 730191) received an FDA Warning Letter dated June 2, 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 16, 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 SL Follen Company MARCS-CMS 730191 — June 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Stuart L. Follen Recipient Title President SL Follen Company 5050 SW Griffith Dr. Suite 101 Beaverton , OR 97005 United States Issuing Office: Office of Inspections and Investigations United States June 2, 2026 WARNING LETTER Re: CMS #730191 Dear Mr. Follen: On April 6, 2026 through April 10, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of SL Follen Company located at 5050 SW Griffith Dr. Suite 101, Beaverton, OR 97005. 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 Fresh Pineapple imported from (b)(4) 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 acknowledge receipt of your response dated April 23, 2026 in which you stated you requested your foreign supplier to include the Food Safety Modernization Act Produce Safety Rule Add-on Module Version 1.3 in their third-party audit, and the foreign supplier responded that the Produce Safety Rule module could be added to the next audit. They anticipated the audit with the Produce Safety Rule module to be completed in late 2026. 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: Fresh Pineapple imported from (b)(4) located in (b)(4) . During our inspection you provided the following: (b)(4) audit report for (b)(4) for the audit conducted between (…
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
- 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.
- Has SL Follen Company had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for SL Follen Company as of 2026-06-16. Argus ingests new FDA enforcement records daily.
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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). FDA Cites SL Follen Company in 2026-06-02 Warning Letter — Foreign Supplier Verification Program (FSVP). Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-sl-follen-company-2026-06-02-warning-letter
"FDA Cites SL Follen Company in 2026-06-02 Warning Letter — Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-sl-follen-company-2026-06-02-warning-letter.
Argus HQ Research. "FDA Cites SL Follen Company in 2026-06-02 Warning Letter — Foreign Supplier Verification Program (FSVP)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-sl-follen-company-2026-06-02-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_sl_follen_company_2026_06_02_warning_letter_2026,
title = {FDA Cites SL Follen Company in 2026-06-02 Warning Letter — Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-sl-follen-company-2026-06-02-warning-letter},
note = {Accessed: July 13, 2026}
}