FDA WARNING_LETTER - Distribuidora Jocorena Inc. - September 08, 2023

On November 30, 2023, the FDA issued a Warning Letter to Distribuidora Jocorena Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 21 to September 8, 2023. Previous inspections occurred in 2021 and 2022. The inspection found the company non-compliant with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). A Form FDA 483a FSVP Observations was issued on September 8, 2023, to which no response has been received.

Failure to address these violations may result in further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) via Import Alert #99-41. The importation of food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

The company must respond in writing