FDA WARNING_LETTER - Brodt Zenatti Holdings LLC - May 17, 2019

On May 17, 2019, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Brodt Zenatti Holdings LLC, prompted by a Salmonella Concord multi-state outbreak linked to Karawan brand tahini imported by the firm. The inspection revealed a significant violation: the firm failed to develop an FSVP for sesame paste tahini manufactured by Karawan Tahini and Halva, as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. This indicates non-compliance with U.S. food safety standards for imported products. Although the firm conducted a voluntary recall and verbally committed to cease importing the product, these actions do not address the FSVP violations. The FDA requires a written response within fifteen working days detailing corrective actions, including documentation of a revised FSVP and implementation records. Failure to correct these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act and Detention Without Physical Examination (DWPE) for all imported products. Importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act. Karawan brand tahini is already subject to DWPE due to Salmonella contamination.