Prior Notice Filing: 7 Common Mistakes That Delay Shipments

What Is Prior Notice?

Prior Notice (PN) is an advance notification that must be submitted to FDA before food articles arrive at a U.S. port of entry. Established by the Bioterrorism Act of 2002 and codified at 21 CFR Part 1, Subpart I, Prior Notice applies to all food for human and animal consumption imported into or offered for import into the United States.

The filing deadlines depend on the mode of transportation:

• Ocean vessel: No more than 15 days and no fewer than 8 hours before arrival
• Air: No more than 15 days and no fewer than 4 hours before arrival
• Rail or truck: No more than 15 days and no fewer than 2 hours before arrival at the U.S. port of entry
• International mail: Before the food is sent to the United States

Mistake #1: Incorrect FDA Product Codes

Every Prior Notice must include the correct FDA product code for the food being imported. FDA uses a hierarchical product code system that is different from the Harmonized Tariff Schedule (HTS) codes used by Customs. Using the wrong product code — or using an HTS code instead of the FDA code — will trigger a PN refusal.

How to avoid it: Use FDA's Product Code Builder tool to find the correct code. Cross-reference with your customs broker to ensure both the HTS and FDA product codes are correct.

Mistake #2: Wrong Arrival Date or Time

Prior Notice must be filed within the correct time window for the mode of transportation. Filing too early (more than 15 days before arrival) or too late (after the minimum hours before arrival) will result in rejection. Additionally, if the actual arrival time changes after filing, you may need to amend the PN.

How to avoid it: Coordinate closely with your shipping company or freight forwarder to get accurate estimated arrival times. Build buffer time into your filing schedule and be prepared to amend if schedules change.

Mistake #3: Mismatched Facility Registration

The foreign facility's FDA registration number listed in the Prior Notice must match the actual manufacturing facility. If the registration number is expired, incorrect, or doesn't match the shipper, FDA will refuse the Prior Notice. This is especially common during biennial renewal periods when registrations may lapse.

How to avoid it: Verify your supplier's FDA registration number before every shipment. Confirm that the registration is active and that the facility name and address match what is listed in FDA's systems. Use Assurentry to ensure your foreign suppliers' registrations remain current.

Mistakes #4–7: Other Common Errors

Mistake #4: Late Filing

Simply missing the filing deadline is one of the most preventable errors. Set up automated reminders tied to shipment departure dates and build Prior Notice filing into your standard import workflow.

Mistake #5: Incomplete Shipper Information

Prior Notice requires the name, address, and registration number of the shipper (the foreign facility). Incomplete or incorrect shipper information will result in a PN refusal under 21 CFR §1.281.

Mistake #6: Not Amending When Shipment Details Change

If the quantity, product, arrival port, or arrival time changes after you file the Prior Notice, you must submit an amendment. Failure to amend can result in detention even if the original PN was filed correctly.

Mistake #7: Filing for Exempt Products

Not all food imports require Prior Notice. Products for personal consumption (in reasonable quantities), food for research, and transshipments are generally exempt under 21 CFR §1.277. Filing incorrect Prior Notices for exempt products can create confusion and may actually cause delays.