FDA entries can involve several different parties. These roles should not be treated as interchangeable simply because the same company sometimes performs more than one role.

Manufacturer / producer

The manufacturing or producing establishment associated with the regulated product. Program-specific registration or establishment identifiers may apply.

Shipper

The party shipping the goods. The shipper is not automatically the manufacturer.

Importer / consignee

The party used for the applicable FDA import declaration. The exact role and data requirements vary by FDA program and entry scenario.

FSVP importer

For covered food imports, the FSVP importer is a specific regulatory role. FDA describes it generally as the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee at entry, it is the U.S. agent or representative of the foreign owner/consignee who has confirmed consent in a signed statement.

FDA requires identifying information for the FSVP importer at entry, including the recognized unique facility identifier where applicable. FDA currently recognizes DUNS as an acceptable UFI for FSVP.

Operational rule

Do not automatically populate every FDA party with the consignor or consignee unless the underlying regulatory role is actually satisfied by that party.

Sources