Why US Agent Service Is Required
Any foreign establishment that manufactures, produces, prepares, and processes a dietary supplement, medical device or drug imported into the US must assign a US agent as its official correspondent.
- A US agent helps in the event of an emergency related to a dietary supplement, medical device or drug.
- In case of an emergency, FDA contacts the US Agent and no other personnel.
- By law, the US Agent must have a residence in US and be physically present in US.
- The US Agent is available to answer any calls from the FDA.