Background

The Food and Drug Administration has issued a list of records that importers are required to maintain under the foreign supplier verification program regulations. FSVP requirements are already in effect for all importers except those that qualify as very small businesses.

The FSVP rule requires importers to verify that the food they are importing into the U.S. has been produced in a manner that meets applicable U.S. food safety standards. To do this importers must develop, implement, and maintain an FSVP that includes verification activities and records of those activities for each imported food from each foreign supplier. During an FSVP inspection an FDA investigator will review the importer’s records to determine their compliance.

The FDA has now made available a list of records required by the FSVP rule to help importers determine which ones they should develop and maintain. This list is organized according to the sections of the rule so importers can readily determine the records required for the sections that apply to them. Not every record on the list will be applicable to each importer, the FDA states, so importers will need to determine whether they are subject to an exemption, standard FSVP requirements, or modified FSVP requirements.

For more information on complying with FSVP requirements, please contact FDA Practice Leader Shelly Garg at (305) 894-1043.

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