Foreign Supplier Verification Program (FSVP): FDA Warning Letter to SL Follen Company, June 2, 2026

FDA Warning Letter — Violations FDA cited at SL Follen Company

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 (b)(4) through (b)(4) (b)(4) audit report for (b)(4) for the audit conducted between (b)(4) through (b)(4) (b)(4) certificate for (b)(4) issued (b)(4) and the corresponding audit report You stated that your foreign supplier is audited under the (b)(4) standard and you obtained documentation of (b)(4) audits and certification from your foreign supplier. However, the records provided are partially in a foreign language with no English translation. It is not clear how these documents would apply to your FSVP program. You also stated that you did not verify the foreign supplier’s compliance with the Produce Safety Rule. 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 import you determine that you are an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public