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FDA Data Shows an Increase in Food Facility Violations for Failing to Develop a Foreign Supplier Verification Program

  • According to the Food and Drug Administration’s (FDA) Inspection Observation Data for the Fiscal Year 2019, the most commonly cited violation during FDA food facility inspections was failing to develop a Foreign Supplier Verification Program (FSVP).  The data, which is prepared by FDA’s Office of Regulatory Affairs, reveals that there were 340 violations for failing to develop an FSVP in 2019.  This data demonstrates that there continues to be an increase in these types of violations, as FDA cited 289 importers for the same violation in 2018 and 108 importers in 2017.

  • The FSVP is a mandate of the 2011 Food Safety Modernization Act (FSMA) that requires importers to verify that food that they import into the United States is not adulterated or misbranded with respect to food allergen labeling, and produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act.

  • In 2019, FDA announced its issuance of the first warning letter using its authority under the FSMA Final Rule on FSVP.  FDA has noted that it “will take more 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.”  The increase in violations for failing to develop an FSVP and FDA’s announcement indicates that FDA will continue to enforce FSMA’s FSVP rule.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 58


About this Author

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...