FDA Clearance, Handled.
Prior Notice prepared in minutes, validated against FDA rules, and filed by our team through FDA PNSI — so your shipments clear customs without delay.
Refused at the border.
If Prior Notice is not confirmed before arrival, your food must be held at the port. It cannot be delivered to the importer. Storage fees pile up daily while your product spoils.
Resolve a holdPrior Notice Confirmation Number (PNC) not found. Cargo detained.
The 2/4/8 hour rule.
FDA requires notice submission well before arrival. The deadline depends on your mode of transport. Filing late = automatic refusal.
7 Digits between
revenue and refusal.
FDA Product Codes (PIC) are notoriously complex. Our AI deconstructs your product (Industry, Class, Process) to generate the perfect 7-digit code, preventing “Mismatched Product” detentions.
Built for PNSI filing.
No re-keying, no guesswork. Our platform validates every shipment against FDA rules before anything goes out, and our regulatory team files through the FDA Prior Notice System Interface (PNSI) — with a confirmation record for every notice.
We don't sleep.
Neither does trade.
Shipments arrive at 3 AM. Assurentry's filing team and tooling support your notices around the clock, helping get your goods cleared before the sun comes up.
No PDFs. No Faxes.
Just Data.
Stop emailing PDF forms to brokers. Assurentry converts your shipping documents into structured JSON data, reducing transcription errors and speeding up clearance.
Start with the API500 SKUs.
One manifest. Validated.
High-volume importer? Drag and drop your shipment manifest (CSV/Excel). Our system validates every line item against FDA rules and prepares your Prior Notices in bulk — our team files them before your goods arrive.
- Batch Processing
- Manifest Validation
- Automatic Consolidation
Common filing errors
Many detentions trace back to simple, avoidable clerical errors. We automate them away.
Wrong Manufacturer
Listing the shipper instead of the actual manufacturer (FDA FEI required).
Late Submission
Filing after the truck has already crossed the border line.
Mismatched Quantity
Package count on PN does not match bill of lading.
Freight Forwarder vs. Specialist.
Brokers charge high per-line fees and often guess at product codes. We specialize in FDA compliance.
Stop delaying your shipments.
Prepare Prior Notice in minutes, not days. We file it and post your confirmation number to your dashboard.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join the FDA-regulated brands who trust Assurentry for automated compliance.