After a foreign facility submits a registration, FDA will verify that the person or entity identified as the U.S. Agent, such as ITB HOLDINGS LLC, has agreed to serve.
The FDA sends a confirmation notification of a foreign facility registration to the U.S. Agent, to ensure that the U.S. Agent is aware of the connection.
The agency will not confirm any registration or provide the foreign facility with a registration number until the U.S. Agent’s confirmation within 30 days.
If the U.S. Agent wishes to no longer serve the already registered foreign facility, the foreign facility will have 60 calendar days to update the facility’s registration with a new U.S. Agent.
But, in most cases, the registration of the foreign company is simply processed by the U.S. Agent, upon request and payment of a service fee.
More than 1,300 companies used one fictitious address and U.S. Agent information, to register with the FDA and exported products that did not meet U.S. requirements, just to avoid paying U.S. Agent Service Fees. And, that may be the tip of an iceberg.
Foreign establishments or facilities exporting to the United States must identify an FDA U.S. Agent during the registration process. Each foreign establishment may designate only one U.S. Agent.
FDA treats representations by the U.S. Agent as those of the foreign facility, and will consider information or documents provided to the U.S. Agent, the equivalent of providing the information or documents to the foreign facility.
Therefore, most foreign establishments or facilities expect their U.S. Agent to be at least bilingual.
Also, time zones not just in the U.S., but around the world are usually challenging. U.S. Agents working hours can make a difference.
Email exchanges are great when responses are provided the same day. But, additional instant and 24/7 live support chat is much better.
Ready to switch U.S. Agent? October 1 through December 31, each year, is the best time frame. However, that can happen any time.
Get the service your company deserves, at the cost you can afford.
You definitely need the assistance of a U.S. Agent for the following:
● FDA Registration of your company
● FDA Registration of the manufacturer or the exporter (if different)
● Verify that your labels are FDA compliant
● File a Prior Notice for each product and each shipment
● Foreign Supplier Verification Program (FSVP).
Please keep in mind that your Customs Broker including DHL, UPS or FedEx, will not be able to provide such assistance. However, you can count on them to obtain a U.S. Customs or CBP-Assigned Number by submitting an Importer Identity Form (CBP Form 5106).
They simply have different responsibilities:
▪ U.S. Agent.
▪ Importer of Record.
▪ FSVP Importer.
Contact us for additional information.
