What Happens if You Fail an FSVP Inspection: FDA 483s, Warning Letters, and Import Alert The FEI is a unique identifier that FDA uses to identify firms associated with FDA regulated products.

FDA is now placing importers on the Red List of Import Alert 99-41 “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.” This is one of the rare Import Alerts on which FDA places US importers rather than foreign manufacturers and shippers!

All non-exempt food importers can expect to be inspected by FDA to ensure they have adequate FSVPs. FDA investigators will usually conduct FSVP inspections at the importer’s place of business. The inspections are random and may occur any time after the importer imports the foods. Most of the time, FDA will only give a week or less notice for the inspection!

During the first few years following the publication of the FSVP rule in 2017, FDA was lenient in its FSVP inspections and would simply provide non-compliant importers educational materials, advising them how to comply with the FSVP regulation and prepare for future FSVP inspections. However, this “discretionary education” period has long ended. Now, if the investigator finds that the importer does not have FSVPs for all their non-exempt foods or that the FSVPs are inadequate, he or she will likely issue FDA Form 483 to the importer, listing all the investigator’s observed violations of the FSVP regulation.

If the importer fails to correct the violations, FDA may issue a Warning Letter advising the importer that the Agency may take enforcement action if the problems remain unresolved. Warning Letters are published on FDA’s public website, so you should avoid the Warning Letter at all costs!

If the importer is still unable to correct the violations after being issued the Warning Letter, FDA may place the company on the Red List of Import Alert 99-41 under which FDA may now automatically detain the importer’s foods as long as the importer remains on the list. To be removed from the Red List, the importer will need to petition FDAs’ Division of Import Operations, a process that may take several months or longer.

Be sure to Contact us to see how we can assist you in ensuring that you pass FDA’s FSVP inspection!