{"id":193,"date":"2023-03-08T22:49:00","date_gmt":"2023-03-08T22:49:00","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-support\/?p=193"},"modified":"2023-03-08T22:49:00","modified_gmt":"2023-03-08T22:49:00","slug":"responsibilities-of-a-us-agent","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-support\/2023\/03\/08\/responsibilities-of-a-us-agent\/","title":{"rendered":"RESPONSIBILITIES OF A US AGENT"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">All foreign food facilities that engage in manufacture, pack\nor holding of food for human or animal consumption in US are required to <a href=\"https:\/\/www.fdahelp.us\/fda-food-registration.html\">register with FDA<\/a>\nand identify a <a href=\"https:\/\/www.fdahelp.us\/fda_registration\/us-fda-agents-requirements.html\">US\nAgent<\/a> on their registration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All foreign drug establishments that manufacture, repack, or\nre-label drug products and import or offer for import drug products to the US must\n<a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">register with the\nFDA<\/a> and identify a US Agent on their registration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All foreign medical device establishments engaged in the\nmanufacture, preparation, propagation, compounding, or processing of a medical\ndevice imported into the US must identify a US Agent on their <a href=\"https:\/\/www.fdahelp.us\/establishment-registration.html\">FDA registration<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The responsibilities of a US Agent include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Assisting FDA in communications with the foreign\nestablishment,<\/li><li>Responding to questions concerning the foreign\nestablishment&#8217;s products that are imported or offered for import into the US.<\/li><li>Assisting FDA in scheduling inspections of the\nforeign establishment <\/li><li>If FDA is unable to contact the foreign\nestablishment directly or expeditiously, FDA may provide information or\ndocuments to the US Agent, and such an action shall be equivalent to providing\nthe same information or documents to the foreign establishment.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Each foreign establishment must appoint only one US Agent.\nThe foreign establishment must provide the name, address, telephone number, fax\nnumber, and e-mail address of the US Agent.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The US Agent will need to accept such appointment timely.\nThe US Agent must reside or maintain a place of business in US. They must be\navailable to answer the phone during normal business hours.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/\">Liberty Management Group\nLtd.<\/a> can assist you with FDA registration &amp; US Agent service. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Namrata <\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Regulatory Consultant<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>support@libertymanagement.us<\/em><\/p>\n\n\n\n<figure class=\"wp-block-embed\"><div class=\"wp-block-embed__wrapper\">\nhttp:\/\/www.fdahelp.us\n<\/div><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>All foreign food facilities that engage in manufacture, pack or holding of food for human or animal consumption in US are required to register with FDA and identify a US Agent on their registration. All foreign drug establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-support\/2023\/03\/08\/responsibilities-of-a-us-agent\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;RESPONSIBILITIES OF A US AGENT&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[2,64,37],"class_list":["post-193","post","type-post","status-publish","format-standard","hentry","category-food-regulations","tag-fda-registration","tag-register-with-fda","tag-us-agent"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/193","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/comments?post=193"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/193\/revisions"}],"predecessor-version":[{"id":194,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/193\/revisions\/194"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/media?parent=193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/categories?post=193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/tags?post=193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}