FDA WARNING_LETTER - San Juan Produce, LLC - March 25, 2025

On March 25, 2025, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of San Juan Produce LLC, following a previous inspection on May 18, 2023. The inspection aimed to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation in 21 CFR part 1, subpart L. The FDA found significant violations, specifically that the firm failed to develop, maintain, and follow an FSVP for any of the foods it imports, as required by 21 CFR 1.502(a). This fundamental deficiency means the company is not verifying that its foreign suppliers meet applicable U.S. food safety standards. The firm had not responded to the Form FDA 483a issued on March 25, 2025. The letter also highlighted requirements for importers of covered produce (21 CFR part 112) and for very small importers (21 CFR 1.512), including documenting status and obtaining written supplier assurances, which the firm must address if applicable. Failure to adequately address these violations may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz). San Juan Produce LLC must respond in writing within fifteen working days, detailing specific corrective actions, providing supporting documentation, and outlining timelines for achieving full compliance with FSVP regulations.