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WARNING LETTER

SL Follen Company MARCS-CMS 730191 —

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 health protection as those required under section 419 of the FD&C Act (21 U.S.C. 305h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the food from the identified foreign supplier on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Lydia Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Lydia Chan via email at lydia.chan@fda.hhs.gov. Please reference CMS #730191 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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