The US Food and Drug Administration (FDA) requires that any establishment engaged in the manufacture, preparation, propagation, compounding or processing of a drug or device imported into the United States of America (USA) be registered with them. Any manufacturer without a place of business in the USA is designated as a foreign establishment and must appoint and register with the FDA, a United States Agent.
QFI has a fully operational office in the USA, allowing them to act as US Agent for device manufacturers, and from where they defend the manufacturer’s interests at all times. Specifically, QFI perform the following tasks on behalf of the manufacturer:
- Register the foreign establishment and list the devices with the US FDA
- Assist in communications with the US FDA, including responding to questions posed by the US FDA concerning the products imported into the USA
- Assist in scheduling inspections of the manufacturers site by the US FDA
- Handle appropriately any queries received from the US FDA, contacting the foreign establishment where necessary