HST Produce, Inc. – FDA Warning Letter, Jul 7, 2022

On November 7, 2022, the FDA issued a Warning Letter to HST Produce, Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 23 to July 7, 2022, and a previous inspection on October 19-20, 2020. The inspection 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).

Specifically, HST Produce, Inc. failed 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, the firm is required to have an FSVP demonstrating that its suppliers meet U.S. food safety standards, including those under section 419 of the FD&C Act and 21 CFR part 112 (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).

The FDA noted that the firm did not respond to the Form FDA 483a FSVP Observations issued on July 7, 2022. Failure to address these violations may result in refusal of admission of imported food products under section 801(a)(3) of the FD&C Act, placement on detention