FDA Takes First Action Against Importer for FSVP Violations, Though No Import Alert Ready Yet

The Food and Drug Administration is still ramping up to full enforcement of the Foreign Supplier Verification Program regulations, but has already taken action against two importers for FSVP violations that were related to outbreaks of foodborne illnesses, said A.J. Seaborn, chief of the import program development and implementation branch at FDA’s Division of Import Operations.

FDA has not yet issued an import alert for FSVP violations that has been under development “for some time,” said Seaborn, who spoke at Food Safety Tech’s Supply Chain Conference on May 29. Once it does come out, it will likely look similar to “some of the more supply chain-type import alerts that we have,” he said.

But Seaborn said that, for the first time since they began in May 2017, FDA has had two FSVP inspections result in “official action indicated” classifications for importers, whereby FDA mandates that corrective action be taken to address an issue.

Overall, FDA has conducted about 460 out of a planned 880 FSVP inspections for human food in fiscal year 2019. The agency will also begin conducting in FY19 FSVP inspections related to animal food, bringing the total number up to around 900. That’s more than the 792 undertaken in FY18, and the 285 in FY17. Overall, about 60 percent of inspections have resulted in “voluntary action indicated” classifications, which mean violations were found but FDA isn’t mandating action, and 40 percent in “no action indicated” classifications, meaning no issues were found.

In about 500 of those inspections, FDA found that the importer did not develop an FSVP at all, showing the need for education as FDA educates “before and while we regulate,” Seaborn said. Other common issues are a lack of a written hazard analysis, and no written procedures to ensure appropriate foreign supplier verification activities are being conducted.

In one inspection of a major retailer, FDA found several issues related to non-compliance with documentation requirements, showing that importers large and small are still getting used to the FSVP regulations, Seaborn said.

Notably, the inspector found that the retailer relied on third-party auditors to assess its foreign suppliers’ hazards, which FDA had not anticipated when it issued its FSVP regulations. The inspector took that finding back to FDA, and the agency concluded that reliance on a third-party auditor’s review and assessment for hazard analysis is acceptable, as long as the auditor is qualified, Seaborn said. The regulations don’t specify that the qualified individual has to be an employee of the importer, he said.

Meanwhile, FDA has also been ramping up to begin the first year of the Voluntary Qualified Import Program in October, Seaborn said. So far, about 50 notices of intent to participate in the program have been submitted. A recent extension of the application deadline to July 31 will cut down on FDA’s time to review participants, but the agency wants to support participation in the program, he said. A notice setting the user fee for participation, estimated in 2015 at $16,400, will be published in the Federal Register in August, Seaborn said.