Step-by-Step Guide to Submit a Prior Notice?
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How to Submit FDA Prior Notice for Imported Food Products

 

If you are importing food into the United States, you are legally required to submit a Prior Notice (PN) to the U.S. Food and Drug Administration (FDA) before the food arrives. This helps the FDA protect against potential threats to food safety.

 

When Should Prior Notice Be Submitted?

• By Land: At least 2 hours before arrival

• By Air or Rail: At least 4 hours before arrival

• By Sea: At least 8 hours before arrival.

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Late or missing Prior Notices can result in shipment refusal, delays, or FDA enforcement actions.

 

Step-by-Step Guide to Submit a Prior Notice:

1. Register with FDA (if needed):
   You do not need to register with FDA to file Prior Notice, but your foreign food facility must be FDA registered under the Bioterrorism Act.

2. Create an FDA Account (for PN System):
   Go to FDA Prior Notice System Interface (PNSI) and create an account.

3. Prepare Required Information:

   • Name and address of the manufacturer and shipper

   • FDA registration number of the food facility (if available)

   • Name of the food product, including trade name, common name, and brand

   • Quantity, packaging, and lot numbers

   • U.S. importer, owner, or consignee information

   • Carrier and arrival information (air, sea, truck, or rail)

   • Country from which the product is shipped and from where it is grown/produced

4. Log in to PNSI and Submit the Notice:

   • Visit https://www.access.fda.gov

   • Choose “Prior Notice” and follow the guided form

   • After submission, download and print the Prior Notice Confirmation Number

5. Provide the PN Confirmation to Carrier or Broker:
   This number must be included with shipping documents. Customs and Border Protection (CBP) will use it to verify FDA clearance.

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FSVP Plan
Standard FSVP vs Modified FSVP

How to search FDA Registration Number?

What Is the FDA Food Facility Registration Process?

How Can a Foreign Company Export Food to the U.S. Without a U.S. Office?

​FSVP Plan for Food Industry

FSVP Importer and FSVP Agent for foreign supplier