Import Program

_{En Español – https://youtu.be/H_myh2p-eaU    Chinese – 中国人 – https://youtu.be/guyztrx7wRE}

---

Spotlight

Resources for Parents and Caregivers on Imported Infant Formula

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

• Import Refusals
  Next steps, destruction, exportation, list of FDA refusals

Popular Topics

• Import Alerts
• Personal Importation
• International Mail Facilities
• Common Entry Errors

Popular Applications

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

Contact FDA

• General Import Questions: FDA Import Program Contacts Find contact information for general import-related questions.
• Import Shipment or Entry Questions: FDA Import Offices and Ports of Entry Find your local FDA office or port of entry for questions about specific import entries or shipments.
• ACE Questions: ACE Support Contact the ACE Support Center for help with the FDA Supplemental Guide, required data elements, entry submissions rejected by FDA, and other ACE-related technical issues.
• Prior Notice Questions: Prior Notice Team Contact the Division of Targeting and Analysis (DTA) for questions about prior notice requirements, compliance, and the Prior Notice System Interface (PNSI).
• Report a Problem or Complaint: Submit a Report Report concerns such as illegal activity, product quality issues, adverse events, or trade complaints.