FDA WARNING_LETTER - Kari-Fresh LLC - June 28, 2023

On September 29, 2023, the FDA issued a Warning Letter to Kari-Fresh LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 26-28, 2023, and a previous inspection from January 21-March 11, 2021. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The FDA found Kari-Fresh LLC non-compliant with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for imported foods, including fresh cilantro, fresh Persian limes, and fresh green onions. These are "covered produce" under 21 CFR 112.3, requiring an FSVP demonstrating supplier compliance with produce safety standards (21 CFR Part 112).

Kari-Fresh LLC's September 8, 2023, response requesting a six-month extension due to hiring a consultant was deemed inadequate as no supporting documentation or details of corrective actions were provided.

The FDA warned that continued non-compliance 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). Kari-Fresh