FSVP Import Alerts to Present New Challenges for Importers, Former FDA Official Says
Importers will have to be even more wary of import alerts once the Foreign Supplier Verification Program takes effect in May 2017, according to Domenic Veneziano, an independent consultant representing EAS Consulting. Import alerts associated with FSVP could lose business for importers when their suppliers, still able to get their products in, turn elsewhere, while import alerts issued on suppliers could raise FDA scrutiny on importers, Veneziano said, speaking at the Food and Drug Law Institute Enforcement, Litigation and Compliance Conference on Dec. 7 in Washington.
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Once FSVP takes effect, import alerts issued on importers for inadequate FSVP programs will cite failure to comply with Section 805 of the Food, Drug and Cosmetic Act, which directs FDA to implement FSVP, Veneziano said. Unlike other import alerts, the food the importer was bringing in will not be considered adulterated. That means the foreign supplier of the food can find another way to get its product in, including through another importer, he said. Importers will have to take corrective actions as soon as possible, and make sure implementation is in a manner FDA will accept to ensure they are quickly removed from the import alert and able to resume importing, he said.
Although FSVP import alerts could be more dangerous, another difference is that FDA may remove importers based on document reviews instead of full inspections, Veneziano said. “There are occasions where the agency will take a look at data and will remove the person from the import alert rather than going out and doing an inspection,” he said. Though FDA may still conduct an inspection, the agency may first remove the importer and then follow up.
FSVP will also have ramifications for importers when their suppliers get placed on import alert, Veneziano said. “You can guarantee that if an inspection is done overseas and there’s violations, the next recommendation is to do a domestic inspection” of the importer’s FSVP to find out why the importer didn’t find the problem and what it is doing to correct it, he said. It’s going to be even more important for importers to know their supply chain, because problems happening overseas will affect domestic operations, he said.
FDA’s Division of Import Operations is working on a policy to provide a notification to the manufacturer that it has been placed on import alert, said Veneziano, who retired as director of the division earlier this year (see 1607270026). Currently, foreign manufacturers are not notified when they are placed on import alert, Veneziano said. “Oftentimes, what I’m hearing is, ‘I’m on this import alert, I can’t get products in, and I have no idea how that occurred,’” Veneziano said.