{"id":16989,"date":"2025-05-07T11:35:12","date_gmt":"2025-05-07T03:35:12","guid":{"rendered":"https:\/\/greenoo.tw\/?p=16989"},"modified":"2025-05-07T11:35:12","modified_gmt":"2025-05-07T03:35:12","slug":"%e4%bb%80%e9%ba%bc%e6%98%affda-483%e8%a1%a8%e6%a0%bc%ef%bc%9f%e9%80%993%e7%a8%aefda%e6%aa%a2%e6%9f%a5%e5%a0%b1%e5%91%8a%e4%bd%a0%e5%bf%85%e9%a0%88%e7%9f%a5%e9%81%93%ef%bc%81","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/%e4%bb%80%e9%ba%bc%e6%98%affda-483%e8%a1%a8%e6%a0%bc%ef%bc%9f%e9%80%993%e7%a8%aefda%e6%aa%a2%e6%9f%a5%e5%a0%b1%e5%91%8a%e4%bd%a0%e5%bf%85%e9%a0%88%e7%9f%a5%e9%81%93%ef%bc%81\/","title":{"rendered":"\u4ec0\u9ebc\u662fFDA 483\u8868\u683c\uff1f\u90193\u7a2eFDA\u6aa2\u67e5\u5831\u544a\u4f60\u5fc5\u9808\u77e5\u9053\uff01"},"content":{"rendered":"

\u4ec0\u9ebc\u662fFDA 483\u8868\u683c\uff1f\u90193\u7a2eFDA\u6aa2\u67e5\u5831\u544a\u4f60\u5fc5\u9808\u77e5\u9053\uff01<\/h1>\n

\u4f60\u7d55\u5c0d\u60f3\u4e0d\u5230\uff0c\u5728\u7f8e\u570bFDA\u9a57\u5ee0\u904e\u7a0b\u4e2d\uff0c\u7adf\u7136\u670980%\u7684\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u56e0\u70ba\u4e0d\u4e86\u89e3FDA\u6aa2\u67e5\u5831\u544a\u800c\u8e29\u96f7\uff01\u4eca\u5929\u6211\u8981\u70ba\u8de8\u5883\u96fb\u5546\u8ce3\u5bb6\u63ed\u958bFDA\u6aa2\u67e5\u5831\u544a\u7684\u795e\u79d8\u9762\u7d17\uff1a483\u8868\u683c\u3001EIR\u548c\u8b66\u544a\u4fe1\uff0c\u9019\u4e09\u5927\u95dc\u9375\u6587\u4ef6\u7a76\u7adf\u662f\u4ec0\u9ebc\uff1f<\/p>\n

\u4e00\u3001FDA 483\u8868\u683c\u662f\u4ec0\u9ebc\uff1f<\/h2>\n

FDA 483\u8868\u683c\uff0c\u4e5f\u7a31\u70ba\u73fe\u5834\u89c0\u5bdf\u5831\u544a\uff0c\u662fFDA\u6aa2\u67e5\u5b98\u6839\u64dacGMP\u898f\u7bc4\u5c0d\u91ab\u85e5\u4f01\u696d\u8cea\u91cf\u9ad4\u7cfb\u9032\u884c\u73fe\u5834\u6aa2\u67e5\u6642\u767c\u73fe\u7684\u4e0d\u7b26\u5408\u9805\u6e05\u55ae\u3002\u9019\u5c31\u50cf\u662f\u4e00\u4efd\u300c\u554f\u984c\u6e05\u55ae\u300d\uff0c\u76f4\u63a5\u6307\u51fa\u4f60\u7684\u4f01\u696d\u54ea\u88e1\u4e0d\u7b26\u5408\u7f8e\u570b\u6a19\u6e96\uff01<\/p>\n

\u4e8c\u3001FDA 483\u7f3a\u9677\u6709\u591a\u56b4\u91cd\uff1f<\/h2>\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. \u66f4\u53ef\u6015\u7684\u662f\uff0c\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

    \u4e09\u3001\u5de5\u5ee0\u8abf\u67e5\u5831\u544a(EIR)\u662f\u4ec0\u9ebc\uff1f<\/h2>\n

    EIR\u5373Establishment Investigation Report\uff0c\u6aa2\u67e5\u5b98\u54e1\u9664483\u8868\u5916\u9084\u9700\u88fd\u4f5c\u6b64\u5831\u544a\u3002\u9019\u4efd\u5831\u544a\u6703\u572830\u500b\u5de5\u4f5c\u65e5\u5167\u5b8c\u6210\uff0c\u7136\u5f8c\u7531FDA\u8fa6\u516c\u5ba4\u8ca0\u8cac\u4eba\u6aa2\u67e5\uff0c\u6700\u7d42\u6703\u88ab\u8b58\u5225\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(Warning Letter)\u6709\u591a\u56b4\u91cd\uff1f<\/h2>\n

    \u8b66\u544a\u4fe1\u662fFDA\u6700\u56b4\u53b2\u7684\u8655\u7f70\u4e4b\u4e00\uff01\u7576\u6aa2\u67e5\u904e\u7a0b\u4e2d\u767c\u73fe\u56b4\u91cd\u7f3a\u9677\u4e14\u5c0d483\u8868\u683c\u7684\u56de\u8986\u88ab\u8a8d\u5b9a\u70ba\u4e0d\u5145\u5206\u6642\uff0cFDA\u5c07\u7c3d\u767c\u8b66\u544a\u4fe1\u3002\u4f01\u696d\u5fc5\u9808\u572815\u500b\u5de5\u4f5c\u65e5\u5167\u56de\u61c9\uff0c\u8a73\u8ff0\u89e3\u6c7a\u65b9\u6848\u3002\u6700\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8b66\u544a\u4fe1\u6703\u5728FDA\u5b98\u65b9\u7db2\u7ad9\u516c\u958b\uff0c\u9019\u5c0d\u54c1\u724c\u8072\u8b7d\u5f71\u97ff\u5de8\u5927\uff01<\/p>\n

    \u5c0d\u65bc\u6e96\u5099\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u8de8\u5883\u96fb\u5546\u8ce3\u5bb6\u4f86\u8aaa\uff0c\u4e86\u89e3\u9019\u4e9bFDA\u6aa2\u67e5\u5831\u544a\u81f3\u95dc\u91cd\u8981\u3002\u60f3\u7372\u53d6\u66f4\u591aFDA\u5408\u898f\u8cc7\u8a0a\uff0c\u907f\u514d\u8e29\u96f7\uff1f<\/p>\n

    \u60f3\u7372\u5f97\u6700\u65b0FDA\u6cd5\u898f\u8207\u5408\u898f\u6307\u5357\u55ce\uff1f\u7acb\u5373\u6383\u63cf\u7da0\u5708\u5708\uff0c\u52a0\u5165\u6211\u5011\u7684LINE\u597d\u53cb\uff1ahttps:\/\/line.me\/ti\/p\/g2Vc38nLnR<\/a><\/p>\n

    #\u8de8\u5883\u96fb\u5546 #FDA\u5408\u898f #\u53f0\u7063\u8ce3\u5bb6 #\u4e9e\u99ac\u905c\u5168\u7403\u958b\u5e97 #\u570b\u969b\u54c1\u724c #\u5408\u898f\u7d93\u71df #FDA483 #\u8b66\u544a\u4fe1 #\u8de8\u5883\u51fa\u6d77<\/p>","protected":false},"excerpt":{"rendered":"

    \u4ec0\u9ebc\u662fFDA 483\u8868\u683c\uff1f\u90193\u7a2eFDA\u6aa2\u67e5\u5831\u544a\u4f60\u5fc5\u9808\u77e5\u9053\uff01 \u4f60\u7d55\u5c0d\u60f3\u4e0d\u5230\uff0c\u5728\u7f8e\u570bFDA\u9a57\u5ee0\u904e\u7a0b\u4e2d\uff0c\u7adf\u7136\u670980% […]<\/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-16989","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/16989"}],"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=16989"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/16989\/revisions"}],"predecessor-version":[{"id":16990,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/16989\/revisions\/16990"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=16989"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=16989"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=16989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}