FDA routinely requests documentation for entries submitted for FDA review. This page discusses what you need to know when FDA requests documents.
The status of my entry says “documents required.” What does that mean?
If more information is needed to make an admissibility decision the FDA entry reviewer may set the status of your entry to “documents required." 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: Bill of Lading (BOL), Airway Bill (AWB), invoice, and purchase order.
Where applicable, you should also provide FDA with commodity specific certifications (USDA permits, Impact Resistance test results, etc.), packing list/growers list, copies of labeling, documentation stating who the actual manufacturer is, documentation explaining why articles classified as U.S. Goods Returned are being returned, certificate of analysis, intended use statement or End Use Statement, and other related documentation as requested. CBP forms 3461 and/or 7501 should also be provided to the FDA for manual (Non-ABI) entries.
If you are unsure which documents to provide, contact the local FDA Division handling your entry.
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; OR
Use the find an import office contact page to determine your local import division email address, postal address, and/or FAX number to submit documents outside of ITACS.
What if I do not provide documents to FDA?
Failure to provide entry 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.