1. Home
  2. For Industry
  3. Import Program
  4. FDA Import Process
  5. Entry Review
  1. FDA Import Process

Entry Review

Overview

Any FDA-regulated product offered for import into the United States must comply with the same standards as domestic products. Upon offering the goods for import, the FDA determines whether products are admissible into U.S. commerce and may refuse entry of any products that violate or appear to violate FDA’s laws and regulations.  The initial electronic review of FDA-regulated products offered for import is the first step in the “Entry Review” process.

Importers can help ensure a smoother import process by being knowledgeable about their products, suppliers, and compliance requirements, as well as providing complete, accurate, and valid data to their Customs brokers/filers. 

New for 2025: FDA has launched major upgrades to its import oversight capabilities, including the FDA ImportShield Program (FISP) and the advanced System for Entry Review and Import Operations (SERIO+), designed to catch unsafe products faster and strengthen FDA's ability to protect American families.
 

FDA's ImportShield Program

Effective August 4, 2025 

FDA has implemented the FDA ImportShield Program (FISP), which centralizes how the agency reviews products being offered for import nationwide. Key features include: 

  • Coordinated National Response: Instead of each port handling the manual review of certain entries separately, expert teams coordinate efforts across the country to identify and interdict dangerous products more quickly.
  • Harmonized Real-Time Alert System: When FDA discovers a high-risk product at one port – such as tainted infant formula or counterfeit medications – all other ports are immediately alerted to watch for similar dangerous products. 
  • Enhanced Efficiency: ImportShield is based on a successful 2022 pilot program that resulted in 70% faster processing times and identified 36% more high-risk products for further testing. 
  • Increased Reviewer Availability: The program allows for more FDA reviewer availability and collaboration across the national network. 
     

Entry Review Process

For most shipments, the first step in the importation process is submission of entry information to U.S. Customs and Border Protection (CBP). If the shipment contains FDA-regulated products, CBP sends data about those products to the FDA for review under a Customs entry number (with format XXX-XXXXXXX-X). Read more about the Entry Submission process.  

All electronic data sent to FDA about FDA-regulated products is screened by FDA systems. Products transmitted with complete, accurate, and valid data may receive a lower risk score and may be eligible for a release without further review. For more information about how the electronic system assesses risk, visit the Entry Screening page.

Any electronic entry that does not receive a release by FDA’s system is routed for human review by the FDA ImportShield Program. Some reasons this may happen include:

  • products identified as higher risk;
  • entries that do not contain all the necessary information;
  • products that appear to be subject to Detention without Physical Examination (DWPE) (or Import Alert); and
  • products identified for examination or sampling, either on a surveillance basis or specifically targeted.

ImportShield (FISP) reviewers will assess the information that was submitted about your product(s) to determine the product’s admissibility (i.e., resulting in release or refusal). FDA entry reviewers use internal databases to assist in the review process.  See Import Systems.

Based on the results of the initial human review, an ImportShield (FISP) reviewer may take one or more of the following actions:

Release of the product

NER reviewers may issue a release of the product. This means the product can be distributed into U.S. commerce.  A release does not preclude future FDA action if a problem is found later.

Request for additional information

If the data transmitted in the in the electronic entry is not sufficient to make an admissibility decision or there appears to be missing, inaccurate, or invalid data, the ImportShield reviewer may request additional information. 

 

Request for Entry Documents (Documents Requested status)

If additional information is needed to make an admissibility decision, an entry reviewer may require entry documents or request specific information related to the product. The entry documents may contain information to help verify compliance with certain requirements, verify information submitted in the electronic data and may also contain additional pieces of information such as copies of product labels, certificates, ingredient lists, processing records, analytical information, etc. which can be used in determining admissibility.

The FDA’s Import Trade Auxiliary Communications System (ITACS) allows for the electronic submission of entry documentation and goods availability information. ITACS is FDA’s preferred method for receiving entry documents.

Visit our Document Required Status page for more information.

Examination/sample collection of the product 

If the FDA entry reviewer cannot verify admissibility based on electronic data or entry documents, an examination of the product may be warranted. An examination may also be warranted for surveillance or specifically targeted. This examination may consist of any combination of a field examination, label examination and/or sample collection. FDA personnel are trained in examination and sample collection techniques; the results of the examinations and the analytical results for samples collected will be used to determine the admissibility of the product.

Visit our Examination & Sample Collection page for more information.

Request detention of the product

Based upon the review of the entry information, there may be the appearance of a violation for several reasons. This may be due to the product and/or manufacturer being subject to Detention without Physical Examination (DWPE), also known as Import Alert, or because compliance with a particular requirement cannot be verified (for example, if the declared manufacturer of a drug product cannot be found in FDA’s drug registration database).

In these situations, FDA’s entry reviewers may request detention of your product based on the appearance of a violation. ImportShield reviewers forward requests for detention to the FDA Compliance Branch for further review.

Entry Review Systems

ImportShield reviewers utilize applications such as SERIO+ Entry Review, PREDICT, and internal systems to assist in the review process. With the implementation of SERIO+, these tools will be integrated into a single, more efficient platform. System for Entry Review and Import Operations (SERIO+). 

Full Implementation: March 2026 

FDA is modernizing its technology by replacing its outdated import review platform with the advanced System for Entry Review and Import Operations (SERIO+). Benefits include: 

  • Integrated Platform: Streamlines FDA's import review process by integrating multiple tools and databases into one comprehensive system 
  • Faster Access: Allows inspectors to access comprehensive information more quickly 
  • Seamless CBP Integration: The new system preserves critical connectivity with Customs and Border Protection's systems, enabling rapid entry of FDA-regulated products into the review workflow  
  • Improved Efficiency: Enables FDA staff to update information and re-screen products more efficiently, helping ensure faster decisions on product safety while maintaining thorough oversight 
     

Manual or “non-electronic” entry process

Entries not submitted electronically will be reviewed by FDA manually. The decision-making process for FDA’s entry reviewers remains the same whether the entry is submitted through the electronic system or through a manual process. If you encounter a situation where you must submit an entry to FDA but cannot do so electronically, please contact your local FDA office to find out the procedure you should follow.

Contact the FDA ImportShield Program (FISP)

Industry stakeholders can access the FDA Import Trade Communications Guide for detailed contact protocols and special shipment procedures under the nationalized review system. This comprehensive resource provides step-by-step information for communicating with ImportShield (FISP) teams, handling time-sensitive shipments, and additional resources. Access the guide here: FDA Import Trade Communications Guide

 



Back to Top