Ensuring Compliance with FDA Prior Notice Filing for Food Imports

In the global food supply chain, compliance with U.S. FDA import regulations is not optional—it’s essential. One of the most critical components of importing food into the United States is the FDA Prior Notice (PN) Filing, mandated under 21 CFR 1.278–1.285. This requirement helps the FDA evaluate and respond to potential threats to food safety, product integrity, and public health before the shipment enters U.S. borders.

For food importers operating under the Foreign Supplier Verification Program (FSVP), ensuring accurate and timely Prior Notice submissions is a key responsibility. At FSVPServices.com, we simplify this complex process with expert-led support that ensures your shipments remain compliant, traceable, and audit-ready.

What is Prior Notice?

The FDA requires that notice be given in advance of any shipment of human or animal food intended for import into the United States. This Prior Notice must include detailed information about the shipment, including product identity, manufacturer, shipper, importer, arrival time, and intended recipient. Failure to file Prior Notice correctly and on time can result in refusal of entry, shipment holds, or regulatory penalties.

How Prior Notice Connects with FSVP Compliance

The Foreign Supplier Verification Program (FSVP), outlined in 21 CFR 1.500–1.514, places the burden of food safety assurance on U.S. importers. This includes verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards. Proper Prior Notice filing is not only a separate FDA requirement but also supports the importer’s supply chain traceability, documentation accuracy, and regulatory readiness—key elements of FSVP implementation. Integrating Prior Notice submissions into your FSVP documentation strategy enhances transparency and strengthens your position during FDA inspections.

Our Service Offering: Prior Notice Filing & Submission

At FSVPServices.com, we offer a streamlined, end-to-end Prior Notice Filing and Submission Service designed to keep your import activities fully compliant. Service Fee: $785.00 USD per product/shipment Scope of Service Includes:

• Complete preparation and electronic filing of FDA Prior Notice
• Verification of product data, shipping timelines, and documentation accuracy
• Integration with CBP (Customs and Border Protection) systems
• Recordkeeping for traceability and audit preparedness
• Regulatory alerts and compliance monitoring for each shipment

Why Choose FSVPServices.com?

✔️ FSVP-aligned approach: Our services are tailored to meet both FDA and FSVP documentation requirements. ✔️ Regulatory expertise: Managed by Consultare Inc. Group, a U.S. compliance company with deep FDA regulatory experience. ✔️ Reduced risk of shipment delays or detentions: Accurate filings ensure your goods move through customs smoothly. ✔️ Audit-ready documentation: We maintain traceable, verifiable records in case of FDA inspections.

Conclusion