Under the FDA’s Foreign Supplier Verification Program (FSVP), importers have a key responsibility: ensuring that the food they bring into the U.S. is produced safely. Per FDA guidelines, food produced outside the US must meet the same safety standards as those produced domestically. Part of that process is reviewing their foreign supplier.
Evaluating Foreign Suppliers
Every importer must review the following when assessing a supplier:
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Hazard analysis
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Identify potential biological, chemical, and physical hazards that could affect the safety of the food.
- Biological hazards include Salmonella, E. coli, and Listeria as well as viruses such as Norovirus and parasites such as Cryptosporidium.
- Chemical hazards include radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved additives, food allergens.
- Physical hazards can include glass or metal that enters the food during production, warehousing, or transportation.
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Applying Hazard Controls
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Determine the entities (i.e. the foreign supplier, their ingredient supplier) applying hazard controls.
- Review the supplier’s manufacturing procedures, sanitation, and preventive controls to ensure food is produced under safe conditions.
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Regulatory compliance
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Verify that the supplier follows applicable FDA food safety regulations and has a good compliance record.
- Determine if the foreign supplier is subject to an FDA warning letter or import alert.
- Check third-party audit results, conduct onsite testing, and the supplier’s documentations.
- How quickly and effectively they’ve corrected past issues?
- Evaluate other relevant elements, such as how the supplier stores and transports food products.
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This is just an outline of the foreign supplier evaluation process. Experience is needed to comprehensively assess foreign suppliers.
Here at Ken Lehat & Associates, we can help importers evaluate their foreign suppliers, ensuring all paperwork is in compliance. We have 60+ years’ experience helping importers comply with FDA regulation. We look forward to working with you.
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