US FDA Registration:
FDA is the federal agency that is responsible for overseeing most of the U.S. food supply. FDA is responsible for protecting the public health by ensuring the safety and security of our nation’s food supply; this is a vital part of FDA's mission and a primary task of FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The FDA requires all domestic and foreign facilities that manufacture, process, pack, or hold food or beverages, for importation or distribution in the United States to register with the FDA. Any imported foods or imported beverages not in compliance with FDA’s food facility registration requirements may be refused by FDA or CBP.
The U.S. Food and Drug Administration (FDA) ensures that all foods and beverages manufactured in, imported into or sold in the United States are safe, wholesome and properly labelled. The U.S. FDA Food Safety Modernization Act ("FSMA") gives the FDA greater authority to prevent food safety problems and concerns, and increases the agency’s enforcement powers in order to achieve higher rates of compliance with the law’s requirements.
If your company is on an Import Alert, your goods will not be released for distribution by the U.S. FDA until you can prove your goods are in compliance with applicable FDA regulations, and FDA must review and approve your compliance. This will occur for EACH importation until you successfully Petition to be removed from the Import Alert list Companies are placed on the Import Alert list when the company’s products are subject to detention without physical examination. This typically occurs when there is a history of violations; the U.S. FDA's determines that there are health risks imposed by your company's products; or potentially because of a history of violations in the country or region of manufacturer.