FDA WARNING_LETTER - Ikal LLC - May 01, 2023

The FDA conducted Foreign Supplier Verification Program (FSVP) inspections of Ikal, Llc. on April 26-May 1, 2023, and previously on May 14-20, 2021, at their San Diego location. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, for imported foods, specifically fresh avocados. The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for any of the foods imported, including fresh avocados, as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). As an importer of "covered produce," the firm must ensure its suppliers meet public health protection standards equivalent to those under section 419 of the FD&C Act and 21 CFR part 112. The firm's written response, detailing plans for FSVP training and consultant engagement, was deemed inadequate due to a lack of supporting documentation for planned or completed corrective actions. Ikal, Llc. is required to respond within fifteen working days with specific corrective actions and supporting documentation. Failure to comply may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE), and prohibition of importation under section 301(zz) of the FD&C Act.