{"id":16995,"date":"2025-05-07T11:37:09","date_gmt":"2025-05-07T03:37:09","guid":{"rendered":"https:\/\/greenoo.tw\/?p=16995"},"modified":"2025-05-07T11:37:09","modified_gmt":"2025-05-07T03:37:09","slug":"%e3%80%90%e9%9c%87%e9%a9%9a%e3%80%91fda%e6%aa%a2%e6%9f%a5%e5%a0%b1%e5%91%8a%e4%b8%89%e5%a4%a7%e9%a1%9e%e5%9e%8b%e8%a7%a3%e6%9e%90%ef%bc%81%e5%8f%b0%e7%81%a3%e8%b7%a8%e5%a2%83%e8%b3%a3%e5%ae%b6","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/%e3%80%90%e9%9c%87%e9%a9%9a%e3%80%91fda%e6%aa%a2%e6%9f%a5%e5%a0%b1%e5%91%8a%e4%b8%89%e5%a4%a7%e9%a1%9e%e5%9e%8b%e8%a7%a3%e6%9e%90%ef%bc%81%e5%8f%b0%e7%81%a3%e8%b7%a8%e5%a2%83%e8%b3%a3%e5%ae%b6\/","title":{"rendered":"\u3010\u9707\u9a5a\u3011FDA\u6aa2\u67e5\u5831\u544a\u4e09\u5927\u985e\u578b\u89e3\u6790\uff01\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u5fc5\u8b80\u6307\u5357"},"content":{"rendered":"

\u3010\u9707\u9a5a\u3011FDA\u6aa2\u67e5\u5831\u544a\u4e09\u5927\u985e\u578b\u89e3\u6790\uff01\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u5fc5\u8b80\u6307\u5357<\/h1>\n

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    \n
  1. \u5c0d\u98df\u54c1\u4f01\u696d\u53ef\u80fd\u7d44\u7e54\u4e8c\u6b21\u9a57\u5ee0\uff0c\u9084\u6703\u6309\u5c0f\u6642\u6536\u8cbb<\/li>\n
  2. \u91dd\u5c0d\u5df2\u4e0a\u5e02\u7522\u54c1\uff0cFDA\u6703\u7d44\u7e54\u5c08\u696d\u6703\u8b70\u78ba\u5b9a\u6574\u6539\u6216\u53ec\u56de\u8a08\u5283<\/li>\n
  3. \u4f01\u696d\u53ef\u80fd\u56e0\u4e0d\u7b26\u5408GMP\/cGMP\u8981\u6c42\u88ab\u5217\u5165\u9ed1\u540d\u55ae\uff0c\u6536\u5230\u8b66\u544a\u4fe1<\/li>\n<\/ol>\n

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    EIR\u5373Establishment Investigation Report\u5de5\u5ee0\u8abf\u67e5\u5831\u544a\uff0c\u662f\u6aa2\u67e5\u5b98\u54e1\u9664483\u8868\u683c\u5916\u9084\u9700\u88fd\u4f5c\u7684\u91cd\u8981\u6587\u4ef6\u3002\u9019\u4efd\u5831\u544a\u901a\u5e38\u572830\u500b\u5de5\u4f5c\u65e5\u5167\u5b8c\u6210\uff0c\u7d93FDA\u8fa6\u516c\u5ba4\u5be9\u6838\u5f8c\uff0c\u6703\u88ab\u6b78\u985e\u70ba\u4ee5\u4e0b\u4e09\u7a2e\u72c0\u614b\uff1a<\/p>\n

    1\ufe0f\u20e3 NAI: No Action Indicated \u2013 \u4e0d\u9700\u63a1\u53d6\u63aa\u65bd\uff08\u6aa2\u67e5\u671f\u9593\u672a\u767c\u73fe\u9055\u898f\u9805\u76ee\uff09
    \n2\ufe0f\u20e3 VAI: Voluntary Action Indicated \u2013 \u81ea\u9858\u63a1\u53d6\u63aa\u65bd\uff08\u767c\u73fe\u9055\u898f\u9805\u76ee\uff0c\u4f46\u4e0d\u9700\u5b98\u65b9\u884c\u52d5\uff09
    \n3\ufe0f\u20e3 OAI: Official Action Indicated \u2013 \u5b98\u65b9\u9700\u63a1\u53d6\u884c\u52d5\uff08\u767c\u73fe\u9055\u898f\u9700\u63a1\u53d6\u9032\u4e00\u6b65\u6cd5\u898f\u63aa\u65bd\uff09<\/p>\n

    \u56db\u3001\u8b66\u544a\u4fe1\uff1a\u6700\u56b4\u53b2\u7684\u8655\u7f70<\/h2>\n

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    \u5c0d\u65bc\u8a08\u5283\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u96fb\u5546\u5275\u696d\u8005\uff0c\u4e86\u89e3\u9019\u4e9bFDA\u6aa2\u67e5\u5831\u544a\u81f3\u95dc\u91cd\u8981\uff0c\u9019\u76f4\u63a5\u95dc\u4fc2\u5230\u4f60\u7684\u7522\u54c1\u80fd\u5426\u9806\u5229\u901a\u95dc\u4e26\u5728\u7f8e\u570b\u5e02\u5834\u92b7\u552e\u3002\u5982\u679c\u4f60\u60f3\u78ba\u4fdd\u4f60\u7684\u7522\u54c1\u7b26\u5408FDA\u6a19\u6e96\uff0c\u907f\u514d\u9019\u4e9b\u6f5b\u5728\u98a8\u96aa\uff0c\u8acb\u7acb\u5373\u884c\u52d5\uff01<\/p>\n

    \u8b93\u6211\u5011\u96a8\u6642\u4fdd\u6301\u806f\u7e6b\uff01\u52a0\u5165\u7da0\u5708\u5708LINE\uff0c\u7372\u5f97\u66f4\u591a\u9a5a\u559c\uff1ahttps:\/\/line.me\/ti\/p\/g2Vc38nLnR<\/a><\/p>\n

    #FDA\u6aa2\u67e5\u5831\u544a #\u53f0\u7063\u8ce3\u5bb6 #\u8de8\u5883\u96fb\u5546 #\u4e9e\u99ac\u905c\u5168\u7403\u958b\u5e97 #\u5408\u898f\u7d93\u71df #\u8de8\u5883\u51fa\u6d77 #\u54c1\u724c\u4fdd\u8b77 #\u8b66\u544a\u4fe1 #\u570b\u969b\u96fb\u5546<\/p>","protected":false},"excerpt":{"rendered":"

    \u3010\u9707\u9a5a\u3011FDA\u6aa2\u67e5\u5831\u544a\u4e09\u5927\u985e\u578b\u89e3\u6790\uff01\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u5fc5\u8b80\u6307\u5357 \u4e09\u53e5\u8a71\u5fb9\u5e95\u89e3\u6c7aFDA\u6aa2\u67e5\u5831\u544a\u56f0\u60d1\uff1a\u4e86\u89e3483\u8868\u683c\u3001\u638c […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[45],"tags":[],"class_list":["post-16995","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/16995"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=16995"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/16995\/revisions"}],"predecessor-version":[{"id":16996,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/16995\/revisions\/16996"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=16995"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=16995"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=16995"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}