Import Program

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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
• 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