All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The job of protecting consumers includes an ever-increasing need to oversee imports. 

Imported FDA-regulated products are electronically screened before they enter the U.S. Consumers and importers of imported FDA-regulated products will find helpful information detailed on this website.

How to start importing FDA-regulated products

• Importing FDA-Regulated Products
  Information and requirements for importing FDA-regulated products
• Entry Submission Process
  Information you need to file an entry with the FDA
• Common Entry Errors
  Information regarding common errors to help you provide accurate and complete information to the FDA
• Import Systems
  Information regarding the electronic import systems the FDA utilizes to review and validate entry data and information
• FEI Portal (NEW)
  Look up a FDA Establishment Identifier (FEI) based on a firm name and address or validate an address of an FEI

Is Your Shipment on Hold?

• Check the Real-Time Status of your Entry Now!
  Check entry status, estimated lab completion date, submit documents electronically, provide location for FDA examination, and retrieve Notices of FDA Action in ITACS
• Examination & Sample Collection 
  What to expect when your product is examined/sampled by the FDA
• Actions & Enforcement 
  Types of FDA actions, enforcement and compliance activities
• Import Alerts
  Overview and import alert lists by country, product and number
  Enter key word(s), firm name, product, etc. to search import alerts:  
• Import Refusals
  Next steps, destruction, exportation, list of FDA refusals

Popular Topics

• Import Alerts
• Personal Importation
• International Mail Facilities
• FDA Data Dashboard

Popular Applications

• ITACS
• Automated Commercial Environment / International Trade Data System (ACE/ITDS)
• Product Code Builder
• FEI Portal

Contact FDA

General Import Questions
FDA Import Contacts and Office Locations
Find FDA contact information for general import questions

For Import Entry Questions
FDA Import Offices and Ports of Entry
Find your local FDA office or port for questions regarding specific import entries

For ACE Questions
Contact the ACE Support Center for technical issues related to the FDA Supplemental Guide, required data elements, and general ACE submissions, including entry submissions rejected by FDA.
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