When an entry is transmitted to FDA, we verify that the declared manufacturer and shipper are registered with FDA by comparing the submitted information with CDRH’s establishment registration and listing database. We also use CDRH’s data system to verify that the declared importer is registered.
Listing for the declared product is also verified by comparing the declared product description to CDRH’s establishment registration and listing database.
If the information submitted matches the CDRH establishment registration and listing database, then compliance is verified; if the information does not match, FDA may gather additional information or may detain the product. If a firm lacks the required registration and listing, the product will be subject to refusal.
