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US Agent for Dietary Supplement Foreign Facility

We serve as a US Agent to meet all the criteria required for Dietary Supplement Foreign Facility registration. Our US Agent can answer any questions the FDA may have in the event of an emergency.

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U.S. agent for foreign food facility

Why US Agent Service Is Required

Any foreign establishment that manufactures, produces, prepares, and processes a dietary supplement, medical device or drug imported into the US must assign a US agent as its official correspondent.

  • A US agent helps in the event of an emergency related to a dietary supplement, medical device or drug.
  • In case of an emergency, FDA contacts the US Agent and no other personnel.
  • By law, the US Agent must have a residence in US and be physically present in US.
  • The US Agent is available to answer any calls from the FDA.

Our Responsibilities As A US Agent

We are specialized in helping foreign establishments in the food, beverage, dietary supplement, drug and medical device industries by getting them registered with the US FDA. We help clients navigate through the registration process.

  • We assist the FDA through interactions with the foreign establishment.
  • We respond to FDA questions related to your products or devices that are imported.
  • We can help the FDA schedule communications with the foreign establishment.

While serving as a US Agent for your Dietary Supplement Foreign Facility, we will be liable to the FDA for all the expenses related to re-inspection of your establishment or any product detained at a US port, and handle your failure to comply with a recall order.

US Agent for dietary supplements
Need a US Agent for your Dietary Supplement Foreign Facility Registration?

Please fill out this form. We will get back to you as soon as possible.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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