{"id":239,"date":"2024-03-07T17:13:19","date_gmt":"2024-03-07T17:13:19","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=239"},"modified":"2024-03-07T17:13:19","modified_gmt":"2024-03-07T17:13:19","slug":"u-s-agent","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2024\/03\/07\/u-s-agent\/","title":{"rendered":"U.S AGENT"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Any foreign establishment engaged in the manufacture,\npreparation, propagation, compounding, or processing of a <a href=\"https:\/\/www.fdahelp.us\/fda-food-registration.html\">food<\/a>, <a href=\"https:\/\/www.fdahelp.us\/drugs.html\">drug<\/a>, <a href=\"https:\/\/www.fdahelp.us\/medicaldevices.html\">medical device<\/a>, and <a href=\"https:\/\/www.fdahelp.us\/cosmetics.html\">cosmetics<\/a> imported into the\nUnited States must identify a U.S. agent for that establishment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Information about a foreign establishment\u2019s U.S. Agent must\nbe electronically using the FDA FURLS system or CDER\/ESG and is part of the\nestablishment registration process. Each foreign establishment may designate\nonly one U.S. agent. The foreign establishment should provide the name,\naddress, telephone, and e-mail address of the U.S. agent.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/fda_registration\/us-fda-agents-requirements.html\">Responsibilities\nof a U.S. agent<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The U.S. agent must either reside in the U.S. or maintain a\nplace of business in the U.S and they cannot use P.O. BOX as the address. U.S\nagents must be available to answer the phone or have an employee available to\nanswer the phone during normal business hours.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The responsibilities of the U.S. agent are limited and\ninclude:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Assisting FDA in communications with the foreign\nestablishment, meaning that function as a mediator between the client and the\nFDA.<\/li><li>Responding to questions concerning the foreign\nestablishment&#8217;s products that are imported or offered for import into the\nUnited States,<\/li><li>Assisting FDA in scheduling inspections of the\nforeign establishment and<\/li><li>If FDA is unable to contact the foreign\nestablishment directly or expeditiously, FDA may provide information or\ndocuments to the U.S. agent, and such an action shall be equivalent to\nproviding the same information or documents to the foreign establishment.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group<\/a>, a leading FDA consulting firm provides assistance with <a href=\"https:\/\/www.fdahelp.us\/fda-registration-agent.html\">US agent services<\/a> all foreign food, drug, medical devices and cosmetics establishments. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email: office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a food, drug, medical device, and cosmetics imported into the United States must identify a U.S. agent for that establishment. Information about a foreign establishment\u2019s U.S. Agent must be electronically using the FDA FURLS system or CDER\/ESG and is part of the &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2024\/03\/07\/u-s-agent\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;U.S 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":[25],"tags":[41,42,44,29],"class_list":["post-239","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug-medical-device","tag-fda-cosmetics-registration","tag-fda-drug-registration","tag-fda-food-facility-registration","tag-fda-medical-device-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/239","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=239"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/239\/revisions"}],"predecessor-version":[{"id":240,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/239\/revisions\/240"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}