When the confirmation notification of a foreign facility registration is sent to the facility, a confirmation will also be sent to the U.S. Agent to ensure that the U.S. Agent is aware of the connection with each foreign facility registration.
Additionally, because U.S. Agents would have direct access to a list of facilities identifying them as U.S. Agent, the identification system will limit the number of unauthorized and/or fraudulent U.S. Agent listings. U.S. Agents can also electronically notify FDA that they decline to serve as or no longer serve as the U.S. Agent for a foreign facility.
If the U.S. Agent wishes to no longer serve the already-registered foreign facility, the foreign facility will have 60 calendar days to update the facility’s registration with a new U.S. Agent.