Detailed guides on FDA registration, US Agent requirements and compliance standards for companies exporting to the United States.
Every company that wants to export food, cosmetics or medical devices to the US must register with the FDA. This guide explains what FDA registration is, who has to register and the risks of shipping without it.
The FDA requires every registered facility located outside the US to designate a US Agent. Learn the US Agent’s role, the selection criteria and why it is critical for your company.
FSVP is the US food importer’s obligation to verify its foreign supplier. We explain who is responsible and what is expected of the exporter.
What are the steps in FDA registration for a foreign food facility? The registration requirement, DUNS number, US Agent, registration and renewal, in order.
What must appear on the label of packaged food sold in the US? The Nutrition Facts panel, the nine major allergens and the division of roles between the FDA and USDA.
Every food shipment to the US requires a Prior Notice to the FDA. We explain which foods are covered, the filing deadlines and what happens if no notice is filed.
Products containing animal-origin ingredients such as dairy, eggs, gelatin or collagen need a USDA APHIS permit to be imported into the US. We explain the VS 16-3 application process in detail.
Our team is ready to guide you through the FDA registration process. Contact us now for a free preliminary assessment.
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