FDA Prior Notice - FDA Services

PRIOR NOTICE CONFIRMATION NUMBER

PRIOR NOTICE is a notification to the U.S. Food and Drug Administration (FDA), that a product is being imported or offered for import into the United States, in advance of its arrival at a U.S. port or airport.

FDA will use the information provided with the Prior Notice to determine whether to inspect, sample the article of food when it arrives in the U.S. or deny entry.

Don’t lose your shipment. File a Prior Notice (PN). Save time and money, now.

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FDA PRIOR NOTICE REQUIREMENT

FILE A PRIOR NOTICE

Prior Notice (PN) Confirmation Number is an Affirmation of Compliance, when the U.S. Customs and Border Protection (CBP) entry or admission is filed. Submitting accurate and complete information at the time of entry, and responding in a timely manner to requests for additional documents or information, helps expedite the entry review process.

You must have at your disposal:

FDA Registration Number of the manufacturer, exporter and importer
Air Waybill (AWB) Number from FedEx, UPS, DHL
Bill of Lading (BOL) or Sea Waybill Number from your Freight Forwarder

Advance notice of import shipments allows the FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively.

PRIOR NOTICE DEADLINES

Except for food being sent by international mail (only covers foreign national mail services), Prior Notice must be submitted and the submission must be confirmed by FDA no less than:

2 hours before arrival, if the food is arriving by land by road

4 hours before arrival, if the food is arriving by land by rail

4 hours before arrival, if the food is arriving by air

8 hours before arrival, if the food is arriving by water.

For obvious reasons, filing a Prior Notice this late is never recommended. Furthermore, FedEx, DHL, UPS or your freight forwarder expect you to provide a Prior Notice Confirmation Number, when you drop your package or cargo.

PRIOR NOTICE CONSIGNEE

When a customer or consignee has not been identified, the Third-party Logistics (3PL) where the merchandise will be delivered and stored is the ultimate consignee in Prior Notice submissions.

FDA believes that the facility where the goods are to be delivered should be considered the ultimate consignee in all circumstances.

ITB HOLDINGS LLC as U.S. Agent, files Prior Notices (PNs) on behalf of foreign and domestic companies, upon request.

FDA
PRIOR NOTICE

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FDA REGISTRATION NUMBER

Please keep in mind that FDA Registration Numbers are required to file a Prior Notice. See below for additional information.

FOOD FACILITY

FDA REGISTRATION NUMBER

Before you request a Prior Notice Filing, make sure you have the following:

Manufacturer FDA Registration Number
Exporter FDA Registration Number
Importer FDA Registration Number

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FDA DETENTION

Failure to notify the FDA prior to your shipment arriving in the United States may result in an FDA and U.S. Customs Detention of your products, costly holding fees and potential import ban. Is that really worth it?