Hi,
My company is a contract manufacturer for our customer, and has registered our establishment with FDA. They assigned their US agent as our agent in US as well. Now, my company is going to market our own products in US. According to the regulation in US, only one US agent is permitted. We don't want to use the US agent for our own products. How shall we go about? If we change our agent, will FDA notify the agent that our customer assigned? :confused:

Hello.
I am a U.S Agent for several of our foreign suppliers who make products just for my company. I understand that you were just trying to please your customer in the beginning but your company should have choosen the agent in the first place.

You can the FDA in writing but you must do it within 5 days of making the change. There is a form letter on the FDA website that you could modify for the change.
http://www.fda.gov/cdrh/usagent/usagentnotification.html

Will your customer understand that you need to have a neutral agent which will avoid any conflicts with other U.S. customers. Or are you afraid they will be upset with the change? I have turned down companies because they sell to us as well as to our competitors,as this creates conflicts.

This is the website that lists the agents you can choose from-
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfUSagent/search.cfm

I am not sure if the FDA will notify the current agent once you name a new one but if I find out I will let you know.
Bridget