U.S. FDA Registration and U.S. Agent

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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires all non-U.S. facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.

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The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. The first compliance dates start May 30, 2017.

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The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of U.S. food safety laws in over 70 years. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Register-FDA has been helping food companies comply with US FDA regulations since the implementation of the Bioterrorism Act in 2003.

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