All foreign food facilities that engage in manufacture, pack or holding of food for human or animal consumption in US are required to register with FDA and identify a US Agent on their registration.
All foreign drug establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the US must register with the FDA and identify a US Agent on their registration.
All foreign medical device establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the US must identify a US Agent on their FDA registration.
The responsibilities of a US Agent include:
- Assisting FDA in communications with the foreign establishment,
- Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the US.
- Assisting FDA in scheduling inspections of the foreign establishment
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.
Each foreign establishment must appoint only one US Agent. The foreign establishment must provide the name, address, telephone number, fax number, and e-mail address of the US Agent.
The US Agent will need to accept such appointment timely. The US Agent must reside or maintain a place of business in US. They must be available to answer the phone during normal business hours.
Liberty Management Group Ltd. can assist you with FDA registration & US Agent service.
Namrata
Regulatory Consultant
support@libertymanagement.us