Overview

All imported shipments of FDA-regulated products are reviewed by FDA and must comply with the same standards as domestic products. 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.  All entries are reviewed by FDA’s electronic system; further reviews are conducted by FDA employees, often referred to as entry reviewers. This page will tell you about how FDA screens entries for compliance with FDA’s laws and regulations.

The first step in the importation process is submission of entry information to CBP. After an entry is electronically submitted to Customs and Border Protection (CBP), the data is then sent to FDA for review. If you would like more information on the submission process, refer to our entry submission process page.

When FDA’s system receives your entry information, it is electronically screened. For more information about how the electronic system assesses risk, visit the entry screening page. If your entry contains all the necessary information and is identified as lower risk, it may receive a release without FDA manual review.

Any entry that does not receive a release by FDA’s system is routed for manual review. Some reasons this may happen include: products identified as higher risk; entries that do not contain all the necessary information; or products identified for examination or sampling, either on a surveillance basis or specifically targeted.

FDA uses the term “entry review” to describe the FDA process of reviewing the information that was submitted about your product. FDA’s entry reviewers do this in order to determine admissibility. FDA entry reviewers use databases such as Import Entry Review, PREDICT and internal databases to assist in the review process.

Based on the product type and information received, FDA may take one or more of the following actions when reviewing your entry:

• Release the product
• Request additional information, either through:
  • Review of entry documents (documents required); and/or
  • Examination/sample collection of the product
• Request detention of the product

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Release of the product

Entry 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.

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Request for additional information

Sometimes the information contained in the electronic entry is not sufficient to make an admissibility decision. Review of the shipping and entry documents may help in this determination and sometimes examining the product or collecting a sample for laboratory analysis may be needed.

Review of entry documents 

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 can often contain information to help verify compliance with certain requirements, can help verify information submitted in the electronic data, and may also contain certificates or analytical information 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 

An FDA entry reviewer may determine an entry will be set up for FDA examination. 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.

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Request detention of the product

Based upon the review of the entry information, the appearance of a violation may be present. This may be due to the product and/or manufacturer being subject to detention without physical examination (DWPE), or because compliance with a particular requirements 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. Entry reviewers forward requests for detention to the FDA Compliance Branch for further review.

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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.

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