FDA

US FDA and the US Agent of Record

Many foreign (to the US) and domestic companies that make Food, Beverage, Dietary Supplement, Medical Device or Drugs that are marketed in the United States are required to register their company with the Food and Drug Administration (FDA). All foreign companies must designate a US Agent of Record, if this is not done then shipments to the US ill be denied entry.

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What is a US Agent of Record? The US Agent of Record is responsible for being the adviser, consultant, and contact that the US FDA has with any domestic or foreign company that wants to do business in the United States.

What type of company needs a US Agent of Record?

Food, Beverage, or Dietary Supplements: Every owner, operator or person in charge of a facility that manufacturers, processes, packs or holds food or beverages for human or animal consumption in the United States must register.

Drugs: Domestic and International companies or groups that manufacture, re-label, pack drug products in the US are required to register with the FDA.

Medical Device: Any company either domestic or foreign, including distributors and importers, involved in a medical device being sold in the US must register their company and facility with the FDA and list all devices. Foreign companies must also designate a US Agent of Record.

What does a US FDA Agent of Record do?

The US Agent of Record with the FDA has a very important role to play in your company being in the US market.

  1. The US Agent of Record will submit the registration for your facility or warehouse with the FDA
  2. The US Agent of Record is the contact in case of an emergency and is required to assist the FDA in communicating with you and your facility
  3. The US Agent of Record transmits questions to and from the US Government which you will need to answer in a timely fashion
  4. The US Agent of Record will also communicate the scheduling of inspections that may be required by the US FDA. Your Agent will be required to receive documents and information from the FDA and send that information to you

Lastly a few tips when choosing a US Agent of Record:

Updated January 2021

  • Your US Agent of Record could be but does have to be independent of your importer and exporter. Now with some import law requirements you will need more immediate clearances and responses to government requests.
  • Your US Agent of Record should only communicate with you make sure to have a specific position at your company in charge of direct (US time based) communication
  • Your product and reputation is the most important part of your business, do not let your product integrity be led by profit or volume
  • A US Agent should provide the following points of service in your contract
    • US Food Facility Registration (only food, beverage, and dietary supplements)
    • Filing of Prior Notice (fee based)

WestWind Group is here to serve as your US Agent for the FDA Registration, we would be happy to consult with you to see which products best fit your needs as a company