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FSVP Warning Letters on the Rise

Back at it Again: Uptick in FDA Warning Letters over FSVP Violations
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This week, FDA publicly posted a handful of Warning Letters to importers over Foreign Supplier Verification Program (FSVP) violations. The FSVP regulation, part of the FDA Food Safety Modernization Act (FSMA), requires importers to perform certain risk-based activities to verify that human and/or animal foods that they import into the U.S. meet U.S. food safety standards.

In an August 1 Warning Letter to DF Global, FDA reports that the importer failed to conduct a hazard analysis for the foods it imports (honey and various teas), and also failed to meet foreign supplier verification activities. FDA also noted that a third-party onsite audit report revealed several compliance concerns with the foreign supplier, which the Company failed to reevaluate as required by the regulations.

Similarly, in a September 12 Warning Letter to C. Liberatore LLC, FDA found that the importer failed to develop, maintain and follow an FSVP for the foods the company imported including peppers and tomatoes. The Warning Letters sends a reminder that even covered produce must comply with the FSVP regulations.  FDA’s Warning Letter to Vero USA Corporation on September 26, similarly was based on the firm not developing, maintaining, and following an FSVP for imported foods such as paprika chips, snacks (corn puffs) and pasteurized white cheese-feta.

FDA’s recent FSVP activity seems to have lifted the pandemic-related pause of the last two years, and we can only expect additional FSVP inspections and Warning Letters to issue. The Warning Letters send a reminder that all FSVP Importers should have on file a written FSVP plan for each food that they import. Please let us know if you have any questions on your FSVP responsibilities, and/ or need assistance with the development or review of FSVP plans.

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