FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act (FSMA) regulations. Under the FSVP rule, importers must take steps to verify that their foreign suppliers produce food that satisfies U.S. food safety standards. FDA issued the Warning Letter to the importer of tahini implicated in a recent Salmonella outbreak. According to the FDA, the importer did not have an FSVP in place for the imported tahini. This memorandum summarizes the Warning Letter and provides analysis of the key takeaways for FSVP enforcement.

Summary of Warning Letter

Brodt Zenatti Holdings LLC (Brodt Zenatti) is the FSVP importer for tahini from Karawan Tahini and Halva (Karawan), located in the West Bank, which was implicated in a multi-state Salmonella Concord outbreak earlier this year. Brodt Zenatti recalled the tahini on May 23, 2019, and according to FDA, the company voluntarily agreed to stop importing the product. FDA placed the Karawan tahini under detention without physical examination (DWPE) per Import Alert 99-19 on May 30, 2019, as a consequence of being found contaminated with Salmonella.

Read More: FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA


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