Import Alert for FSVP Non-Compliance Sees Sharp Uptick in New Listings in Last 3 Months

FDA is adding importers to its import alert for those not in compliance with the Foreign Supplier Verification Program at an ever-increasing rate, with more than half of importers subject to import refusal under the alert added within the last three months.

Of the 22 importers on Import Alert 99-41 as of Nov. 26, 11 were added by FDA since Sept. 1. Six were added in September, followed by three in October and two so far in November. The import alert provides for "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation."

An FDA spokesperson said that addition to the import alert results from a failure by importers to correct violations identified by FDA in an initial inspection by the time FDA returns for a second inspection. FDA began conducting FSVP inspections in 2017, “with a focus on helping importers understand the requirements and appropriate corrective actions that should be taken if deficiencies are observed,” the spokesperson said. Reinspections have been ongoing since 2019.

Importers may request removal from the import alert, and must submit information to demonstrate any FSVP compliance issues have been resolved. To date, four importers have been removed from Import Alert 99-41, the agency spokesperson said.