FDA Prior Notice Filing and Submission Services for U.S. Food Imports

FDA Compliance Support Based on 21 CFR 1.278–1.285 (Prior Notice of Imported Food) Service Fee: $785.00 USD per Product / Shipment

To ensure full compliance with U.S. FDA Prior Notice regulations, this service supports importers, foreign suppliers, and logistics coordinators with end-to-end preparation and filing of Prior Notice (PN) submissions in accordance with FDA and Customs Border Protection (CBP) import entry requirements. Service ensures timely notification, accurate documentation, and traceable records for food shipments entering the United States.

Scope of Work

Shipment Information Collection and Verification

Gather and confirm required shipment details for PN submission:

• Product name, code, and quantity (by unit and container size) • Lot or batch codes • Manufacturer, grower, or consolidator information • FDA Food Facility Registration numbers • Country of origin and production • Anticipated arrival date, time, and U.S. port of entry • Importer, owner, shipper, and ultimate consignee information • Transportation carrier details (e.g., SCAC, IATA codes) • Shipment documents (e.g., waybill, planned shipping route) Validate that the anticipated arrival aligns with FDA’s permitted PN submission window.

FDA Registration and FSVP Importer Verification

• Confirm that the foreign facility and U.S. importer are properly registered with the FDA under the Food Facility Registration rule. • Verify the identity of the FSVP Importer as required under 21 CFR 1.509 and confirm if Prior Notice requirements apply under FSVP.

Prior Notice Form Completion and Submission

• Complete the Prior Notice Form via the FDA’s Prior Notice System Interface (PNSI) or coordinate with the customs broker using ABI/ACE. • Populate all mandatory fields including: ◦ Submitter and transmitter details ◦ FDA product code and food description ◦ Arrival port, date, and estimated time ◦ Carrier and mode of transport ◦ Manufacturer and shipper information ◦ Importer and consignee contact details • Submit the completed PN form and confirm FDA receipt • Record and deliver the official Prior Notice Confirmation Number

Deliverables

Prior Notice Confirmation Package

• FDA-issued Prior Notice Confirmation Number • Submission documentation, including shipment details, confirmation screen, and timestamped filing records

Submission Record File

• Organized and traceable documentation archive for compliance review, audit purposes, and customs coordination

Fees and Turnaround

Package	Description	Fee	Turnaround Time
Per Product / Shipment	Full Prior Notice submission, recordkeeping, and confirmation	$785.00 USD	Within 1–2 business days of receiving all complete data

Ideal For:

U.S.-based importers, brand owners, or co-packers seeking to establish or upgrade a fully compliant FSVP system tailored to FDA expectations and audit-readiness.