Responsibilities of the US FDA Agent
A US FDA Agent has to be a resident of the United States or one should have a place of business in the US. The manufacturer can appoint the same US agent as their Office Correspondent, but it is not mandatory. At least one US agent is mandatory to appoint!
Along with the assistance to FDA for communications, response to the questions regarding the sold products & scheduling inspections of your facilities, one might also be provided with the information or your submission documents.
After submitting the electronic copy, the US Agent shall provide the confirmation to complete the process. A Verification mail will be sent to the US Agent to do that. Even his consent would be required. In case of rejection from the US Agent’s side, the same notification will be sent to the manufacturer and the company will have to look for a new Agent for itself!
To handle such paramount responsibilities, it is very essential to appoint a responsible, professional, and reliable agent for your company.
