Understanding the FDA PREDICT Risk Screening System: How Import Decisions Are Made

The FDA processes millions of import entries each year, and it cannot physically examine every shipment. To allocate its inspection resources effectively, the agency relies on the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting — known as PREDICT — an automated risk-scoring system that evaluates every import entry and flags the highest-risk shipments for examination. For foreign manufacturers, PREDICT is the invisible gatekeeper that determines whether your shipment clears quickly or gets held for days or weeks. Understanding what factors PREDICT considers and how to build a compliance history that lowers your risk score is one of the most practical steps a foreign exporter can take to ensure smooth US market access.

How PREDICT assigns risk scores

PREDICT evaluates multiple data points for each import entry and generates a risk score that determines the likelihood of the shipment being selected for FDA examination. The factors include the product type (certain product categories, such as seafood, spices, and dietary supplements, carry inherently higher risk scores due to historical violation rates), the country of origin (countries with higher rates of violative shipments receive higher country-level risk scores), the manufacturer's compliance history (facilities with previous violations, Warning Letters, import refusals, or import alert listings receive higher risk scores), the importer's compliance history, and the specific characteristics of the entry (such as first-time importers, unusual product-country combinations, or entries with filing discrepancies).

PREDICT also incorporates data from FDA sampling programs, laboratory test results, adverse event reports, and intelligence from other government agencies and international regulatory partners. The algorithm is continuously updated based on new data, which means that a manufacturer's risk score is dynamic — it changes over time as new compliance information is added. A facility that was flagged for a Salmonella-positive shipment two years ago will have a higher risk score than it would have had without that finding, but the risk elevation diminishes over time if subsequent shipments are clean.

What happens when a shipment is flagged

Shipments flagged by PREDICT are routed to FDA import screeners for review. The screener evaluates the entry and determines the appropriate action: release without examination, document review (checking labeling, registration status, and filing accuracy), physical examination (visual inspection of the product at the port), or sample collection and laboratory analysis. The specific action depends on the reason for the flag — a labeling concern may result in document review, while a food safety concern may result in sample collection for pathogen or contaminant testing. During any examination hold, the shipment remains at the port or in a bonded warehouse, and the importer bears all storage and handling costs.

How to build a favorable PREDICT profile

The most effective way to reduce your PREDICT risk score is to maintain a consistent, clean compliance record. This means keeping your FDA facility registration current and accurate at all times, ensuring that every shipment has accurate and complete Prior Notice (for food), maintaining product labels that comply with all applicable US requirements, operating under food safety plans, HACCP plans, or CGMP systems that produce consistently safe products, and responding promptly and thoroughly to any FDA inquiries or inspection findings. Each clean shipment that enters the US without a violation contributes to a positive compliance history that lowers your PREDICT score over time.

PREDICT and import alert interactions

PREDICT works in conjunction with the FDA's import alert system. When a facility or product is listed on an import alert, PREDICT automatically assigns the highest risk level to entries from that facility, resulting in Detention Without Physical Examination (DWPE) — the shipment is held without the FDA needing to examine it. Removal from an import alert through the green list process resets the PREDICT flag, but the facility's historical compliance data remains in the system and continues to influence risk scores. Even after removal from an import alert, a facility may experience elevated scrutiny for a period as PREDICT gradually adjusts the risk score based on new clean entries.

How FDABridge helps manage import risk

FDABridge ensures that the regulatory foundations of your import compliance — facility registration, US Agent designation, and accurate filing information — are always current. Clean, accurate registrations contribute to a positive PREDICT profile and reduce the likelihood of examination delays. Visit fdabridge.com to see our registration services or fdabridge.com/contact to discuss how we can help strengthen your import compliance posture.