Under the Code of Federal Regulation 807.40(b) the Food and Drug Administration requires that a foreign establishment must designate a United States (U.S.) FDA Agent to act as their official correspondent. We have a proven track record assisting companies in registrations and Listings with FDA. As an U.S. FDA Agent of your company, we can ensure that your company is in compliance with the FDA regulations.

WHAT IS THE DEFINITION OF A FOREIGN FACILITY?

US FDA rule states that all foreign establishments that manufacture any of the following products must have a designated agent in the USA:

  • Medical device manufacturers
  • Human drug manufacturers
  • Animal drug manufacturers
  • Biologics manufacturers
  • Foreign food facilities
  • Dietary Supplement manufacturer
  • Cosmetic manufacturers
  • Food contact substance manufacturers

WHAT WILL YOUR U.S. AGENT DO?

Based on the responsibilities outlined by the U.S. FDA, a U.S. Agent is responsible for the following activities:

  • U.S. Agent Program for Pharmaceutical / Medical Device Manufacturers
  • Keep a physical office in the USA.
  • Available, if the US FDA wants to reach out to the foreign manufacturer regarding a particular product regarding any safety issues.
  • Provide updates to the US FDA regarding establishment registration and product listing.
  • Be responsible all communications between the US FDA and the Company, i.e., upcoming inspections of the foreign site.

In addition to the responsibilities of the U.S. Agent, the foreign facility has the following responsibilities:

  • Provide their Agent an update of changes to the Establishment registration (e.g., address, change in ownership)
  • Notify their Agent of any new products or changes to already listed products (e.g., dropping them from the product line)
  • Notify their Agent of changes in telephone numbers, fax numbers or email addresses.

Please contact us for further information about our U.S Agent Services. We may be able to assist you.

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