JJR GLOBAL INC. – FDA Warning Letter, Aug 10, 2023

On December 1, 2023, the FDA issued a Warning Letter to JJR Global Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 9-10, 2023. Previous inspections occurred in February-March 2021 and August 2018. The inspection found the company non-compliant with 21 CFR part 1, subpart L, and section 805 of the FD&C Act, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Although the company provided a foreign supplier's food safety plan, it did not demonstrate a review of these documents or explain their application to an FSVP.

JJR Global Inc.'s August 15, 2023, response, stating plans to develop FSVPs after visiting suppliers, was deemed inadequate due to a lack of supporting documentation. Failure to address these violations could lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz). The