FDA WARNING_LETTER - Jalisco Fresh Produce, Inc. - February 24, 2025

The FDA issued a warning letter to Jalisco Fresh Produce following an inspection on February 24, 2025, at their Los Angeles facility. Previous inspections occurred from November 30 to December 16, 2020, and October 7 to 14, 2022. The inspections aimed to assess compliance with the Foreign Supplier Verification Program (FSVP) under section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which mandates risk-based activities to ensure imported food meets U.S. safety standards.

The FDA identified significant violations, including Jalisco Fresh Produce"s failure to develop, maintain, and follow an FSVP for the foods they import, such as fresh produce potentially classified as "covered produce." This non-compliance could lead to actions under section 801(a)(3) of the FD&C Act, including refusal of food admission into the U.S. and detention without physical examination.

The FDA acknowledged Jalisco Fresh Produce"s response dated March 6, 2025, indicating plans to hire a third party for FSVP assistance. However, the response lacked supporting documentation of corrective actions. The FDA requires a written response within 15 working days detailing corrective measures, including documentation of FSVP implementation and any additional compliance information. Failure to address these violations may result in further regulatory actions. Correspondence should be directed to Sandra K. Wangen, Compliance Officer, with reference to CMS # 710484.