All foreign food, drug, and dietary supplement facilities are required to have a United States Agent to act as the domestic communications representative for that facility. The U.S. Agent must be located in the United States and must be available to be contacted by FDA 24 hours a day, 7 days a week, in case an emergency that requires this kind of urgency occurs. When FDA contacts a facility's U.S. Agent, the facility itself is considered to have been contacted. Consequently, it is critical that there is a clear communications pathway between the facility and the U.S. Agent.
R. FLORA & ASSOCIATES, INC. functions as the U.S. Agent for a number of foreign facilities. Let us be your U.S. Agent as well.
Domestic facilities are not required to have a U.S. agent.
We look forward to helping you with your regulatory needs.
R. FLORA & ASSOCIATES, INC.
250 Space View Drive
Grants Pass, OR 97526-8865
Or use our contact form.
Here you will find current information on:
RoboForm Everywhere - Keeps your logins and bookmarks safe and accessible and acts as a form filler.