Import Program – Food and Drug Administration (FDA)
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.
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
Information and requirements for importing FDA-regulated products
* Entry Submission Process
Information you need to file an entry with the FDA
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
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
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
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
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
What to expect when your product is examined/sampled by the FDA
* Actions & Enforcement
Types of FDA actions, enforcement and compliance activities
Types of FDA actions, enforcement and compliance activities
* Import Alerts
Overview and import alert lists by country, product and number
Overview and import alert lists by country, product and number
* Import Refusals
Next steps, destruction, exportation, list of FDA refusals
Next steps, destruction, exportation, list of FDA refusals
Industry Notices and Guidance Documents
Guidance Documents
Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Search for all FDA official guidance documents and other regulatory guidance
This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.
Browse Guidance Documents by Topic
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