FDA WARNING_LETTER - Cantoro Food Market - May 21, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Cantoro Food Market on May 12-21, 2022, following a previous inspection in November 2019. The inspection revealed significant violations of section 805 of the FD&C Act and the implementing FSVP regulation in 21 CFR part 1 subpart L. The firm failed to develop, maintain, and follow an FSVP for imported foods, including specific deficiencies for tomato paste, dried Turkish figs, and spaghetti pasta. Key violations included not conducting a written hazard analysis for each imported food type as required by 21 CFR 1.504, failing to document review and assessment of hazard analyses, and not evaluating foreign supplier performance and food risk per 21 CFR 1.505(a). Additionally, the firm did not perform required foreign supplier verification activities, including determining appropriate activities and frequencies, or conducting/documenting verification activities as per 21 CFR 1.506. The provided third-party audit certificates were insufficient, lacking details on procedures, FDA compliance assessment, and qualified auditor documentation. The FDA requires a written response within fifteen working days detailing corrective actions, including a revised FSVP and implementation records. Failure to comply may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act and potential detention without physical examination (DWPE) under Import Alert #99-41, as well as prohibition under section 301(zz).