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

Source: https://www.keypedia.com/records/warning_letter/brodt-zenatti-holdings-llc/107c4758-25ea-4d1c-bf2b-3d50ea2c9b15

> FDA WARNING_LETTER for Brodt Zenatti Holdings LLC on May 17, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Brodt Zenatti Holdings LLC
- Inspection Date: 2019-05-17
- Product Type: Food
- Office Name: Division of Southeast Imports
- Summary: 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.

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/ruth-p-dixon/9c1382c8-baa0-4f06-a7d3-151e54eaebbc)

Company: https://www.keypedia.com/companies/brodt-zenatti-holdings-llc/8438c4a7-af52-4838-acc6-7f75215a1de7

Office: https://www.keypedia.com/offices/division-of-southeast-imports/919f1cd1-7774-46f7-b8ec-18c4a31f1024