FDA WARNING_LETTER - SL Follen Company - April 10, 2026

The FDA issued a Warning Letter to SL Follen Company following an inspection conducted from April 6 to April 10, 2026, at its Beaverton, Oregon, facility. The inspection sought to verify compliance with the Foreign Supplier Verification Program (FSVP) requirements under the Federal Food, Drug, and Cosmetic Act. These regulations mandate that importers perform risk-based activities to ensure that food imported into the United States meets domestic safety standards. The primary violation identified was SL Follen Company"s failure to develop, maintain, and follow an FSVP for its imported products, specifically fresh pineapple. While the company provided some documentation, such as third-party audit reports, the records were partially in a foreign language without English translations. Furthermore, the company failed to verify that its foreign supplier adhered to the Produce Safety Rule, which governs the safe growing, harvesting, and packing of produce. Although the company responded to initial findings by noting that future audits would include necessary safety modules, the FDA found this response inadequate due to a lack of immediate documentation or proof of corrective actions. The FDA requires SL Follen Company to submit a written response within 15 working days detailing their corrective measures and providing evidence of a functional FSVP. Failure to address these violations may result in the FDA refusing entry of the company"s imports or placing them on a detention list.