The US Food and Drug Administration (FDA) is ramping its enforcement of the Food Supplier Verification Program (FSVP) for imports to the United States, with an increasing number of inspections and warning letters to importers noting FSVP deficiencies. The FDA is actively conducting both remote and on-site inspections. Many of the FSVP inspections involve remote inspection of electronic records.  Typical violations found by FDA 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.

US Importers who 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. Unlike with other Import Alerts, an importer cannot be removed from the Import Alert just by showing five non-violative shipments.  Instead, the importer will need to demonstrate compliance with the FSVP requirements.

A sample notice is found at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/imad-international-llc-613268-03292021 .

FDA has provided resources and training materials for importers. Go to this link and scroll down to “Industry Assistance.”