FDA WARNING_LETTER - FUENTES FARMS LLC - August 01, 2022

On October 14, 2022, the FDA issued a Warning Letter to Fuentes Farms LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from July 28 to August 1, 2022, and a previous inspection from December 15-17, 2020. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L.

The FDA found that Fuentes Farms LLC was not in compliance with FSVP requirements for imported foods, specifically failing to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). This includes a lack of an FSVP for imported fresh produce, which is "covered produce" under 21 CFR 112.3. As an importer of covered produce, the company must have an FSVP demonstrating that its suppliers meet U.S. food safety standards, including those in 21 CFR Part 112 (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).

The company received a Form FDA 483a FSVP Observations on August 1, 2022, but no response was received. Failure to address these violations may result in refusal of admission of imported food under Section 801(a)(3) of the FD&C Act,