Before you consider exporting any food products, medical devices, drugs or cosmetics, you must first register your facility or establishment with the U.S. Food and Drug Administration, to get your FDA Registration Number.
A product is misbranded if manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered. Such product may be detained by the FDA, then refused admission, and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days.
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- Manufacturers, exporters and importers are expected to have an FDA Registration Number
- Filing the required Prior Notice is not possible, unless you can provide the FDA Registration Number of the manufacturer, exporter and importer
- Shipments without FDA Registration Number will be denied entry by the U.S. Food and Drug Administration and U.S. Customs (CBP)
Join thousands of domestic and foreign food companies:
■ 84,494 Domestic (U.S.) registered Food Facilities
■ 198,232 Foreign registered Food Facilities
As of January 9, 2023 and including:
The FDA electronically reviews all entries submitted through the U.S. Customs and Border Protection (CBP).
Products which do not comply with U.S. requirements at the time of importation are subject to refusal of admission. When entry is made with CBP, importers or their customs brokers will include the Harmonized Tariff Schedule (HTS) code among other declarations. The HTS codes are flagged with indicators to help guide whether the FDA data is or is not required.
U.S. Customs Brokers using the electronic system will be prompted to provide the following information for the FDA:
- Commodity and subtype
- Product code
- Product description
- Country code identifying where the product was produced, sourced, grown, or harvested
- Names and addresses of manufacturer, shipper, importer, delivered to party
- FDA Registration Number or FDA Establishment Identifier (FEI)
- Contact information
- Estimated arrival date and time (not be transmitted to the FDA for review until 5 days before the arrival date)
- FDA Affirmation of Compliance (mandatory in some instances)
- Quantity and value (voluntary submission)
- Additional data elements may apply for certain products.
The FDA Registration Number assigned to each facility after the submission of a Food Facility Registration (FFR), is a 11-digit number.
FDA will not complete a registration, or provide a registration number, until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.
An FDA Establishment Identifier (FEI) Number is issued to track inspections of regulated medical device or drug establishments. FEI numbers are also used to track establishments user fee payments. Unlike the FDA Registration Number, the FEI has 10 digits.
Please keep in mind that no new FDA Registration or Renewal can be completed without a DUNS Number. The Data Universal Numbering System, abbreviated as DUNS or D-U-N-S, is a proprietary system developed and managed by Dun & Bradstreet Inc. Obtaining a DUNS Number takes 30 days and is free (in the United States).
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