FDA WARNING_LETTER - ALWAYS FRESCO LLC - November 30, 2023

On February 22, 2024, the FDA issued a Warning Letter to Always Fresco LLC following Foreign Supplier Verification Program (FSVP) inspections on November 29-30, 2023, and March 30, 2023. The inspections, conducted at 5701 S 35th St Ste 3, McAllen, TX, revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation (21 CFR part 1, subpart L).

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including fresh produce classified as "covered produce" under 21 CFR 112.3. As an importer of covered produce, Always Fresco LLC is required to have an FSVP demonstrating that their suppliers meet U.S. food safety standards, specifically those under section 419 of the FD&C Act and 21 CFR part 112 (Standards for Produce Safety).

An FDA Form 483a FSVP Observations was issued on November 30, 2023, but no response has been received. Failure to adequately address these violations may result in further action, including refusal of admission of imported food under section 801(a)(3) of the FD&