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FDA Issues First Warning Letter to Food Importer Under FSVP

On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP).  As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP compliance date began May 30, 2017, however, there are a range of compliance dates according to a number of considerations.

The warning letter, dated July 30, was issued to Brodt Zenatti Holdings LLC in Jupiter, Florida who imported tahini from the Israel-based manufacturer, Karawan Tahini and Halva. In May, the tahini was implicated in a Salmonella outbreak and was voluntarily recalled. In response to the Salmonella outbreak, FDA conducted an FSVP facility inspection, and found that the importer was in significant violation of the FSVP rule. As discussed in the warning letter, the importer did not develop an FSVP for the tahini as required by section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. Within 15 working days, FDA has requested a response to the warning letter that demonstrates plans to correct or evidence that they have corrected the violations. Should the importer fail to correct the violations, they may be placed on the newly established Import Alert #99-41.

Since 2017, FDA has been conducting FSVP inspections in order to help importers understand the requirements and how to take corrective actions if deficiencies are observed. FDA will continue to take steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk. Additionally, as outlined in FDA’s Strategy for the Safety of Imported Food, FDA is committed to working with importers to come into compliance with all applicable FSMA regulations, including FSVP.  FDA’s Strategy is guided by four goals:

  1. Food offered for import meets US food safety requirements

  2. FDA border surveillance prevents entry of unsafe foods

  3. Rapid and effective response to unsafe imported food

  4. Effective and efficient food import program.

An overview of the Strategy can be found here.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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