Seven Elements of a Successful Foreign Supplier Verification Program

Seven Elements of a Successful Foreign Supplier Verification Program

Denis Storey
October 13, 2020

On-Demand Webinar: Learn from an FSVP Lead Instructor about what to do today to protect your business and keep consumers safe.

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On-Demand Webinar: Staying Compliant with the Temporary FSVP Policy

Join FSVP Lead Instructor James Chu for expert advice on how to comply with temporary FSVP policy updates so you can take the necessary steps to protect your customers and your brand.

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The FDA’s Foreign Supplier Verification Program (FSVP) provides greater oversight into the products coming into the country to ensure “importers would be required to perform certain risk-based activities to verify food imported into the United States has been produced in a manner that provides the same level of public health protection as required of domestic food producers.” 

Generally, the FDA asks whoever has a financial stake in ensuring the food coming in will be up to the standards the FDA has established. If you’re the U.S. owner or cosigning at the time of entry, you’re the importer for this rule’s purposes. If there’s no owner or cosigner at the time of entry, then the FDA will look at the U.S. agent or representative for the foreign owner of a cosigner.

What are the seven components of a successful FSVP program?

  1. Compliance status review of foods and suppliers. FSVP expects importers to review the compliance history of their foreign suppliers and identify any compliance issues. Elements of the analysis should include “FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).”

  2. Hazard analysis. Importers need to analyze the hazards associated with each food they import, including the likelihood and severity of the hazard if it were to occur.

  3. Supplier verification activities. Importers must provide sufficient assurances through verification activities that potential risks are actively identified, controlled, and monitored. Verification activities can include on-site audits, periodic sampling, and review of foreign supplier documentation.

  4. Corrective actions (if necessary). Importers are required to address any complaints received about the imported food by investigating the cause and taking appropriate action.

  5. Periodic reassessment of FSVP. Every three years, importers need to reassess their FSVPs. The exception is if the importer is aware of new information about potential hazards associated with food (e.g., source of raw materials, product formulation). In that case, the reassessment needs to occur sooner.

  6. Importer identification at entry. All importers will need to “obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number for their company and to ensure that, for each food product offered for importation into the United States, their name and DUNS number are provided electronically when filing for entry with Customs and Border Protection.”

  7. Recordkeeping. The FDA is taking more steps to increase the number of records we keep. Under this rule, the FDA requires importers to maintain records related to compliance status, foreign supplier verification activities, hazard analyses, investigations, corrective actions, and FSVP reassessments. What’s unique is that the FDA says the importer needs to keep a certain amount of records the agency can access. As part of a successful program, the importer also needs to have food safety records from the foreign supplier. All documents must be subject to FDA availability.

The FDA expresses a preference for electronic records. They haven’t done that on the other rules, but there’s a visible indication in this rule that it’s what the FDA prefers, shown in two ways:

  • The importer needs to provide electronic access to records immediately upon review. Typically, if the FDA is coming and asking for documents, they will come to the facility and make or receive copies. If you’re importing products from Japan, the FDA doesn’t want to wait.

  • Companies must maintain all records in a way that’s not subject to deterioration.

Check out our on-demand webinar, where James Chu, FSVP Lead Instructor and Supplier Quality Manager at John B. Sanfilippo & Son Inc., offered insight on how to comply with temporary FSVP policy updates. You can watch it here

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