FDA Cracking Down on Foreign Supplier Requirements for Imported Foods

Under the Microscope - FDA Inspections

Trade Update • APRIL 12, 2021

The U.S. Food and Drug Administration is reportedly stepping up enforcement of its Foreign Supplier Verification Program for imported products, with an increasing number of inspections and warning letters (such as this recent example) to importers being issued for failing to meet with FSVP requirements.

While the FDA continues to make on-site inspections, owing to the ongoing COVID-19 pandemic, many of the FSVP inspections lately involve the remote examination of electronic records. Typical violations found by FDA during its recent inspections include:

  • No written hazard analysis for each type of imported food;
  • Failure to develop, maintain and follow a Foreign Supplier Verification Program for each type of imported food product;
  • Failure to establish and follow written procedures to ensure that imported products are coming from approved foreign suppliers;
  • No documented evaluation of the foreign supplier’s performance and the risk posed by the food.

Importers who ignore warnings and continue to violate the FSVP requirements will be placed on Import Alert 99-41 and the food product giving rise to the violation will be refused admission.

Note: Unlike with other Import Alerts, an importer cannot be removed from IA 99-41’s “Red List” just by showing five non-violative shipments. Instead, the importer will need to demonstrate compliance with the FSVP requirements

Need More Information?

Extensive guidance regarding the FSVP is available here.

Should you have any questions about FDA’s enforcement policy in this respect, don’t hesitate to contact one of our knowledgeable trade experts.

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