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At Register FDA, we guarantee that your products, from food and beverages to biologics and OTC drugs, adhere to the highest regulatory standards.
Frequently Asked Questions
Answers To Commonly Asked Questions
"Does possessing a food facility registration authorize me to sell my products in the U.S.?"
Simply being registered does not imply FDA approval of your products, nor does it endorse them.
"Is it mandatory for foreign food facilities to appoint a U.S. Agent for registration purposes?"
Yes, foreign facilities must designate a U.S. Agent to facilitate communication with the FDA.
"What duties does a U.S. Agent for FDA food facility registration have?"
The U.S. Agent must reside in the United States and aid in both communication with the FDA and the coordination of inspections.
"Can I complete my food facility registration initially and appoint a U.S. Agent afterward?"
No, registration activation necessitates having a U.S. Agent from the outset.
"Is it possible to replace my U.S. Agent after the food facility registration?"
Yes, you are permitted to appoint a different U.S. Agent after registration.
"What options exist for a foreign company without a U.S. representative to act as a U.S. Agent?"
A third-party service, like FDA Specialist, can be employed to fulfill the role of U.S. Agent.
"What information is required for obtaining a U.S. FDA food facility registration?"
You need to provide specific details about your company and the types of food it manages. A DUNS number is also necessary for registration.
"If our manufacturer is registered with the FDA, does it mean their products are approved for sale in the U.S.?"
No, having a registration does not equate to FDA approval of the products.
"Can the U.S. Agent for my food facility registration be based outside the United States?"
No, the U.S. Agent needs to be based within the United States.
"Will the FDA accept a food facility registration from a non-U.S. government?"
No, to market foods in the U.S., facilities must be registered directly with the U.S. FDA.
