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21 CFR 1.276 • Import Clearance

Instant FDA Clearance.

File Prior Notice in seconds. Direct API integration with FDA PNSI and CBP ACE systems ensures your shipments clear customs without delay.

FDA Accepted
256-Bit Encrypted
24/7 Monitoring
In Transit
Container #8942
OriginNaples, IT
DestinationNewark, NJ
ETA4h 12m
Cleared
Prior Notice Confirmed
CONFIRMATION #
2026-PN-8942X
BORDER ALERT: UNANNOUNCED INSPECTION SURGE - PORT OF LA/LONG BEACH
ENFORCEMENT UPDATE: INCREASED SCRUTINY ON SEAFOOD IMPORTS
SYSTEM STATUS: ACE PORTAL EXPERIENCING DELAYS
REMINDER: 2-HOUR DEADLINE FOR ROAD SHIPMENTS
COMPLIANCE ALERT: PRODUCT CODE 37C-E-15 REQUIRES ADDITIONAL DATA
BORDER ALERT: UNANNOUNCED INSPECTION SURGE - PORT OF LA/LONG BEACH
ENFORCEMENT UPDATE: INCREASED SCRUTINY ON SEAFOOD IMPORTS
SYSTEM STATUS: ACE PORTAL EXPERIENCING DELAYS
REMINDER: 2-HOUR DEADLINE FOR ROAD SHIPMENTS
COMPLIANCE ALERT: PRODUCT CODE 37C-E-15 REQUIRES ADDITIONAL DATA
BORDER ALERT: UNANNOUNCED INSPECTION SURGE - PORT OF LA/LONG BEACH
ENFORCEMENT UPDATE: INCREASED SCRUTINY ON SEAFOOD IMPORTS
SYSTEM STATUS: ACE PORTAL EXPERIENCING DELAYS
REMINDER: 2-HOUR DEADLINE FOR ROAD SHIPMENTS
COMPLIANCE ALERT: PRODUCT CODE 37C-E-15 REQUIRES ADDITIONAL DATA
Section 801(m) Hold

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 hold
08:00 AM - PORT OF ENTRY
Shipment Arrival
Event Logged
08:05 AM - FDA SYSTEM FLAGGED
Section 801(m) Refusal

Prior Notice Confirmation Number (PNC) not found. Cargo detained.

Status: HOLDCost: $450/Day
08:12 AM - ASSURENTRY INTERVENTION
Filing Corrected & Resubmitted
PNC: 1992-442-221
RELEASED
2H
Road Transport
02:00:00
Minimum filing time before arrival
4H
Air / Rail
04:00:00
8H
Ocean Freight
08:00:00
Mandatory Lead Times

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.

2 Hours for Road
4 Hours for Air/Rail
Code Intelligence

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.

Industry CodeSubclassProcess Indicator
37
Industry
Multiple Food Ware
Verified Match
C
Class
Pizza
Verified Match
E
Subclass
Frozen
Verified Match
15
Process
Heat Treated
Verified Match
Assurentry
Source
API Active
ACE
Direct Link
POST /v1/pnsi/submit Authorization: Bearer <token> Content-Type: application/json
HTTP/1.1 200 OK "status": "CONFIRMED" "entry_number": "E-9942..."
System Integration

Direct ACE / PNSI bridge.

We don't type manually. Our platform connects directly to the Automated Commercial Environment (ACE), pushing data instantly to FDA and CBP simultaneously.

24/7 Automation

We don't sleep.
Neither does trade.

Shipments arrive at 3 AM. Assurentry's automated filing engine processes notices around the clock, ensuring your goods are cleared before the sun comes up.

99.9%
Uptime
Global
Port Coverage
New York | 09:41 AM
London | 02:41 PM
Shanghai | 09:41 PM
Tokyo | 10:41 PM
24/7
Active Monitoring
0.2s
API Latency
PDF
Digitizing
{
”status“: “confirmed”,
”pnc“: “199221”,
”time“: “14:02”
}
Digital Transformation

No PDFs. No Faxes.
Just Data.

Stop emailing PDF forms to brokers. Assurentry converts your shipping documents into structured JSON data, eliminating transcription errors and speeding up clearance by 10x.

See the API
Enterprise Scale

500 SKUs.
1 Click. 0 Errors.

High-volume importer? Drag and drop your shipment manifest (CSV/Excel). Our system validates every line item against FDA rules and generates bulk Prior Notices instantly.

  • Batch Processing
  • Manifest Validation
  • Automatic Consolidation
Bulk_Upload_Manifest_v2.csv
Drag & Drop CSV Manifest
Up to 10,000 lines
SKU-992-A: Italian Olive Oil
Analyzed
SKU-992-B: Balsamic Vinegar
Analyzed
SKU-992-C: Dried Pasta
Analyzed
SKU-992-D: Canned Tomatoes
Processing

Common filing errors

70% of detentions are caused by simple clerical errors. We automate them away.

#1 Error

Wrong Manufacturer

Listing the shipper instead of the actual manufacturer (FDA FEI required).

Refusal

Late Submission

Filing after the truck has already crossed the border line.

Hold

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.

Comparison
Freight Forwarder
Manual Process
Best Value
Assurentry
Automated
Filing Fee
Per shipment
$195+
$25
Turnaround Time
Automated processing
24-48 Hours
Instant
Platform Access
24/7 Availability
Email Only
Self-Serve Dashboard
Bulk Upload
CSV Import
Manual Quote
Included
ACE Integration
Zero data entry errors
Manual Entry
Direct API

Stop delaying your shipments.

File Prior Notice in seconds, not days. Get your confirmation number instantly.

Frequently Asked Questions

Common questions about this regulatory requirement.

100% FDA Acceptance Guarantee

Secure Your Supply Chain.

Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.

256-bit Encrypted
Instant PDF
4.9/5 Rating
Official US Agent