FDA Agent is a mandatory requirement for foreign food, drug, and medical device establishments who market their product in the USA. FDA agent is for FDA to communicate with the establishment. FDA contact the US Agent to schedule inspections and if not able to contact the establishments directly.
US Agent is required information in section 7 of FDA food facility registration form, without completing this field the registration will not complete. Also, FDA will assign registration number only if the US Agent confirm the assignment. For food facility, US Agent can be a person on company in the USA. In case if a re-inspection required, FDA will send the invoice to the US Agent and US Agent is responsible to pay the fees. For drug establishment registration, you should provide the name and DUNS number of your US Agent. Since FDA is requesting the DUNS number the US Agent must be a company in the US having a DUNS Number.
US Agent is not responsible for the product quality or custom clearing or FDA detention issues. It is only for FDA communication. US agent is not required to issue prior notice or medical device reporting.
LMG provide US FDA Agent service to foreign food, drug and medical device establishments.