What information is submitted to CBP and FDA about an FDA-regulated product?
The entry information submitted to CBP and then to FDA includes: • The identification of the product by the tariff code • The entry type • The entry number • The arrival date • The port of entry • The port of unloading • The carrier code • The vessel name and voyage, flight or trip number • The importer and ultimate consignee • The quantity • The value • The country of origin • The bill of lading or airway bill number • The manufacturer • The importer of record • The ultimate consignee The tariff codes are flagged to indicate which products will require FDA review. The additional information that is currently transmitted to FDA includes: • The FDA manufacturer • The FDA shipper • The FDA Country of Production (country of origin) • The complete FDA product code • A description of the article in common business terms • The quantity for each FDA line • Affirmations of Compliance Affirmations of Compliance (AOC) are voluntary data elements that a customs broker or self-filer currently may
