FDA PREDICT System: How the FDA Screens Your Imports at the Border

What Is PREDICT?

PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) is the FDA's automated, risk-based system for screening imported shipments of FDA-regulated products at U.S. ports of entry. Launched in 2011 and continually updated, PREDICT replaces earlier random and manual inspection approaches with a data-driven risk-assessment model.

PREDICT evaluates virtually every shipment of an FDA-regulated product entering the United States and assigns it a risk score that determines whether it will be:

• Passed through with no action
• Flagged for documentary review (examining shipping documents and labels)
• Held for physical examination (the shipment is physically inspected or sampled)

How PREDICT Works

When a shipment entry is filed with U.S. Customs & Border Protection, relevant information is automatically transmitted to PREDICT. The system evaluates hundreds of data points including:

Facility-Level Risk Factors

• Whether the facility is registered with the FDA
• Compliance history of the specific manufacturer (past violations, import alerts, refusals)
• Results of any previous FDA inspections
• Whether the facility has been subject to warning letters
• Age of the facility's registration (newer registrations may score higher risk)

Product-Level Risk Factors

• Product category (some categories inherently score higher risk)
• Country of origin and regional compliance history for that product type
• Past laboratory analysis results for the same product
• Prior shipment history and whether previous samples passed
• Seasonality and time-sensitive safety concerns

Shipment-Level Risk Factors

• Port of entry
• Shipping route and transit countries
• Importer of record history
• Broker or forwarder patterns
• Discrepancies between declared and expected shipment characteristics

What Happens When a Shipment Is Flagged?

When PREDICT assigns a high risk score, FDA personnel at the port of entry receive an alert. They then decide whether to:

• Conduct a documentary review — examining the shipping documents, labeling, and certificates
• Conduct a physical examination — inspecting the actual product, potentially collecting samples for laboratory testing
• Issue a Notice of Detention — formally detaining the shipment pending review

Detained shipments are held at the importer's expense (storage fees accrue immediately) while the FDA completes its review. If the FDA finds a violation, it issues a Notice of Refusal and the shipment must be re-exported or destroyed.

How to Reduce Your PREDICT Risk Score

While you cannot directly control PREDICT's algorithm, you can significantly influence your risk score through good compliance practices:

• Maintain valid FDA registration — Unregistered facilities are automatically high-risk
• Build a clean compliance history — Every shipment that passes cleanly improves your score over time
• Test products before export — Third-party lab testing certifying product safety reduces risk
• Maintain complete and accurate labeling — Label issues are easily detected and trigger documentary holds
• Use consistent import information — Inconsistent declarations between shipments raise flags
• Work with experienced U.S. customs brokers — Proper entry filing reduces paperwork-related holds