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Are you a non-US manufacturer of Foods & Food Products?
Let Wellkang LLC be your reliable US Agent registered with the FDA - U.S. Food and Drug Administration! A world leading consultancy offers you excellent services at very competitive prices!

FDA Requirements for Foods & Food Products:

    Since December 12, 2003,
  • ALL food facilities (both domestic and foreign) MUST be registered with the FDA.
  • Any foreign facilities not registered will have their goods held at the U.S. port of entry or moved to an FDA secure location.
  • All foreign food facilities must include the name of a US Agent with their registration.
  • The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.

What is the definition of a foreign facility?

The FDA has defined a facility as "any establishment, structure, or structures under one management at one general physical location, or in the case of a mobile facility, traveling to multiple locations that manufactures/processes, packs or holds food for consumption in the United States."

This may mean that within your company, you may have only one foreign food facility or multiple foreign food facilities. If your company manages multiple geographically dispersed facilities, then you must register each facility. If there are multiple management teams that manage operations within one building, each of the management teams will need to be registered as an independent facility. If you are unsure, please contact us to clarify how many facilities to register.

How can Wellkang help you?

Wellkang LLC provides services and assists your firm to enter the U.S. Market. We will be your professional US Food agent and help you in the following ways:

  • Serve as your U.S. Agent as required by FDA.
  • Process the FDA registration form for you.
  • Register your company with FDA.
  • Be the communication link between you and FDA.
  • Update/Amend/Maintain your account and make sure you stay in full compliance.
  • Cancel your registration if your facility closes or is no longer required to register.
  • Confirm the FDA registration to third party.
  • Send prior notice of imported food shipment to FDA.
  • Solve import/export problems.

Wellkang LLC is a member company of the Wellkang Group of Companies- a world leading consultancy group in FDA affairs incl. 510(k) PMN submission, UL, CCC Mark, CE Marking. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in Asia, Europe and America. Our staffs speak the major languages.

For more information, please visit our Questions and Answers section.

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