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  4. FDA Import Process
  5. Entry Screening Systems and Tools
  1. FDA Import Process

Entry Screening Systems and Tools

How are import entries screened?

Automated systems help FDA employees speed their review of import entries while targeting FDA resources on the riskiest products.

These systems electronically review your entry and flag risky products or entries that are incomplete or contain inaccurate data. If each line of an entry is properly submitted, a lower-risk product may be allowed to enter domestic commerce without further FDA review.

When a system flags an entry for having incomplete or inaccurate data, FDA reviewers may ask for more information or request physical exam or sampling. For more information on entry review, please visit the Entry Review page.

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What is PREDICT?

PREDICT (Predictive Risk- based Evaluation for Dynamic Import Compliance Targeting) is a risk-based analytics tool FDA uses to electronically screen all regulated shipments imported or offered for import into the United States of America.

PREDICT improves import screening and targeting to prevent entry of adulterated, misbranded, or otherwise violative goods and expedites the entry of non-violative goods. PREDICT uses automated data mining, pattern discovery, and automated queries of FDA databases to determine the potential risk of a shipment. It takes into consideration the inherent risk of a product and also information about the previous history of importers, manufacturers and shippers.

PREDICT presents shipments for further review based on its analytical results. Shipments with lower risk ranks and no other potential risks may be processed through FDA review more quickly than higher risk lines.

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Can I get my PREDICT score?

Since PREDICT is a key investigative tool for FDA's import program, PREDICT scores are not released to customs brokers/entry filers, importers, or the general public. System security controls protect the confidentiality of any proprietary trade information involved in these electronic industry-to-government transactions.

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What is the Import Entry Review System?

The Import Entry Review System is an FDA application used internally to view entry or line documentation, make initial admissibility decisions, and create field work assignments. The application allows FDA employees to effectively process entries in an efficient manner.

The application has the added functionality to quickly request additional specific information from the customs broker/entry filer when the information transmitted in an entry or line is insufficient to make an admissibility decision. Customs brokers/entry filers have the ability to upload the requested documents through the Import Trade Auxiliary Communication System (ITACS), which can be viewed in the Import Entry Review System. With the additional information, the entry reviewer can update the data and rescreen the entry line with the new data, as needed. The entry reviewer can then issue a May Proceed or setup a work assignment. Updating entry information with more accurate and complete data helps PREDICT’s screening results for future shipments.

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