United States Agent

Foreign food, drug, and dietary supplement establishments are required to be registered with FDA and they must have a designated United States agent.  The U.S. agent must reside or maintain a place of business in the United States.  Upon request from FDA, the U.S. agent must assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist 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 directly to the U.S. agent.  Such action shall be considered to be equivalent to providing the same information or documents directly to the foreign establishment.

For a nominal setup fee and a small annual fee R. FLORA & ASSOCIATES, INC. will function as your United States agent.  We have the expertise that you need.  Contact us now and get the ball rolling.