FDA Apostille

FDA Certificate

Posted in FDA Apostille

fda apostilleFDA registration is required for all companies that manufacture, process, pack, or store food or beverages that may be consumed in the United States. Companies located outside the U.S. must designate a U.S. Agent for FDA communications.

What are FDA Export Certificates?

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.

Why do foreign governments want FDA Export Certificates?

In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, for example current Good Manufacturing Practice (cGMP) regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.