For Industry

Documents Required Status

Overview

FDA routinely requires documentation for entries submitted for FDA review. This page discusses what you need to know when FDA requires documents.

The status of my entry says “documents required.” What does that mean?

Often the FDA entry reviewer will set the status of your entry to “documents required” if more information is needed in order to make an admissibility decision. This may be due to incomplete or inaccurate entry information submissions or your product does not appear to be in compliance.

What documents should I provide to FDA?

You should provide FDA with entry documentation which may include the following: CBP Form 3461, CBP Form 7501, Bill of Lading (BOL), Airway Bill (AWB), invoice, purchase order, certificates of analysis, copies of labeling, intended use statement, or other related documentation.

How do I provide the documents to FDA?

You can provide entry documentation to FDA in these ways:

  • Upload the documents into Import Trade Auxiliary Communication System  (ITACS). ITACS is the preferred method of submitting documents to FDA.  This can be done by the importer, customs broker (entry filer) or other responsible party.
  • If you are an importer, you can also upload the documents into ITACS, or provide documents to your customs broker (entry filer), who can submit them to FDA on your behalf.
  • To submit documents outside of ITACS, please use the find an import office contact page to determine your local import division postal address and/or FAX number.

Failure to provide required documentation in a timely manner may result in a delay in processing your entry.

Who should I contact if I have questions regarding the submission of my documents?

You should contact the local FDA office at the port of entry.
 

Page Last Updated: 10/25/2017
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