{"id":9696,"date":"2024-06-05T21:43:19","date_gmt":"2024-06-05T13:43:19","guid":{"rendered":"https:\/\/greenoo.tw\/?p=9696"},"modified":"2026-01-28T12:08:50","modified_gmt":"2026-01-28T04:08:50","slug":"fda-inspection-reports-form-483-eir-warning-letter-guide-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026\/","title":{"rendered":"FDA \u6aa2\u67e5\u5831\u544a\u89e3\u6790\uff1a483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u5dee\u7570\u5b8c\u6574\u8aaa\u660e(2026)"},"content":{"rendered":"<figure class=\"wp-block-image size-full\">\r\n<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-20108\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026.png\" alt=\"FDA \u6aa2\u67e5\u5831\u544a\u5b8c\u6574\u6307\u5357\u5c01\u9762,\u986f\u793a 483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u4e09\u7a2e\u6aa2\u67e5\u7d50\u679c\u985e\u578b\u8207\u5dee\u7570\u8aaa\u660e\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-form-483-eir-warning-letter-guide-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\r\n<h2>FDA \u6aa2\u67e5\u5831\u544a\u662f\u4ec0\u9ebc?\u70ba\u4f55\u53f0\u7063\u696d\u8005\u9700\u8981\u4e86\u89e3?<\/h2>\r\n<p>According to <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides\" target=\"_blank\" rel=\"noopener\">FDA \u6aa2\u67e5\u7a0b\u5e8f\u5b98\u65b9\u6307\u5357<\/a>{:target=&#8221;_blank&#8221;},\u7576 FDA \u5c0d\u98df\u54c1\u8a2d\u65bd\u9032\u884c\u73fe\u5834\u6aa2\u67e5\u5f8c,\u6703\u6839\u64da\u767c\u73fe\u7684\u7f3a\u5931\u56b4\u91cd\u7a0b\u5ea6,\u767c\u51fa\u4e0d\u540c\u985e\u578b\u7684\u6aa2\u67e5\u5831\u544a\u3002<strong>\u53f0\u7063\u98df\u54c1\u696d\u8005\u82e5\u51fa\u53e3\u7f8e\u570b,\u5fc5\u9808\u7406\u89e3\u9019\u4e09\u7a2e\u5831\u544a\u7684\u5dee\u7570\u8207\u61c9\u5c0d\u65b9\u5f0f<\/strong>:<\/p>\r\n<ul>\r\n<li><strong>483 \u8868\u683c(Form 483)<\/strong>:\u5217\u51fa\u6aa2\u67e5\u4e2d\u767c\u73fe\u7684\u300c\u53ef\u89c0\u5bdf\u5230\u7684\u7f3a\u5931\u300d,\u5c6c\u65bc\u521d\u6b65\u901a\u77e5<\/li>\r\n<li><strong>EIR(Establishment Inspection Report)<\/strong>:\u5b8c\u6574\u7684\u6aa2\u67e5\u5831\u544a,\u8a18\u9304\u6240\u6709\u6aa2\u67e5\u7d30\u7bc0<\/li>\r\n<li><strong>\u8b66\u544a\u4fe1(Warning Letter)<\/strong>:\u6b63\u5f0f\u7684\u6cd5\u898f\u9055\u898f\u901a\u77e5,\u8981\u6c42\u7acb\u5373\u6539\u5584<\/li>\r\n<\/ul>\r\n<p>\u9019\u4e09\u7a2e\u6587\u4ef6\u7684\u56b4\u91cd\u7a0b\u5ea6\u8207\u6cd5\u5f8b\u6548\u529b\u5b8c\u5168\u4e0d\u540c,<strong>\u932f\u8aa4\u7406\u89e3\u53ef\u80fd\u5c0e\u81f4\u61c9\u5c0d\u5931\u7576,\u751a\u81f3\u9762\u81e8\u9032\u53e3\u6263\u7559\u6216\u6cd5\u5f8b\u8a34\u8a1f<\/strong>The<\/p>\r\n<h2>\u70ba\u4f55 FDA \u6703\u9032\u884c\u98df\u54c1\u8a2d\u65bd\u6aa2\u67e5?<\/h2>\r\n<p>FDA \u4f9d\u64da <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\" target=\"_blank\" rel=\"noopener\">FSMA(\u98df\u54c1\u5b89\u5168\u73fe\u4ee3\u5316\u6cd5\u6848)<\/a>{:target=&#8221;_blank&#8221;} \u8ce6\u4e88\u7684\u6b0a\u529b,\u5c0d\u570b\u5167\u5916\u98df\u54c1\u8a2d\u65bd\u9032\u884c\u5b9a\u671f\u6216\u4e0d\u5b9a\u671f\u6aa2\u67e5,\u76ee\u7684\u5305\u62ec:<\/p>\r\n<ul>\r\n<li><strong>\u9a57\u8b49 FSMA \u5408\u898f\u6027<\/strong>:\u78ba\u8a8d\u8a2d\u65bd\u662f\u5426\u5efa\u7acb\u9810\u9632\u6027\u63a7\u5236\u8a08\u756b<\/li>\r\n<li><strong>\u8abf\u67e5\u98df\u54c1\u5b89\u5168\u4e8b\u4ef6<\/strong>:\u7576\u767c\u751f\u6c61\u67d3\u6216\u75be\u75c5\u7206\u767c\u6642\u8ffd\u67e5\u6e90\u982d<\/li>\r\n<li><strong>\u4f8b\u884c\u6027\u6aa2\u67e5<\/strong>:\u4f9d\u98a8\u96aa\u7b49\u7d1a\u5b9a\u671f\u6aa2\u67e5\u8a2d\u65bd<\/li>\r\n<li><strong>\u9032\u53e3\u7522\u54c1\u9a57\u8b49<\/strong>:\u91dd\u5c0d\u9032\u53e3\u98df\u54c1\u7684\u5883\u5916\u8a2d\u65bd\u6aa2\u67e5<\/li>\r\n<\/ul>\r\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0d FDA \u98df\u54c1\u8a3b\u518a\u5236\u5ea6\u7684\u6574\u9ad4\u7406\u89e3,\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7e3d\u89bd\u5165\u624b,\u6709\u52a9\u65bc\u5f8c\u7e8c\u5224\u65b7\u4e0d\u540c\u60c5\u5883\u8207\u57f7\u884c\u5dee\u7570\u3002<\/p>\r\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u5b8c\u6574\u6307\u5357|\u53f0\u7063\u98df\u54c1\u51fa\u53e3\u7f8e\u570b\u5fc5\u8b80(2026 \u6700\u65b0)<\/strong><br \/><a href=\"https:\/\/greenoo.tw\/en\/fda-food-registration\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration\/<\/a><\/p>\r\n<hr \/>\r\n<h3>\u5716 2: FDA \u6aa2\u67e5\u5831\u544a\u985e\u578b\u6bd4\u8f03\u5716<\/h3>\r\n<p>&nbsp;<\/p>\r\n<\/figure>\r\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20109\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-comparison-form-483-eir-warning-letter-2026.png\" alt=\"FDA \u6aa2\u67e5\u5831\u544a\u985e\u578b\u6bd4\u8f03\u5716,\u986f\u793a 483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u7684\u5b9a\u7fa9\u3001\u56b4\u91cd\u7a0b\u5ea6\u8207\u56de\u61c9\u671f\u9650\u5dee\u7570\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-comparison-form-483-eir-warning-letter-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-comparison-form-483-eir-warning-letter-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-comparison-form-483-eir-warning-letter-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-comparison-form-483-eir-warning-letter-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-comparison-form-483-eir-warning-letter-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\r\n<figure class=\"wp-block-image size-full\"><hr \/>\r\n<h2>483 \u8868\u683c(Form 483):\u53ef\u89c0\u5bdf\u5230\u7684\u7f3a\u5931\u6e05\u55ae<\/h2>\r\n<h3>\u4ec0\u9ebc\u662f 483 \u8868\u683c?<\/h3>\r\n<p>rely on <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-references\/investigations-operations-manual\" target=\"_blank\" rel=\"noopener\">FDA \u6aa2\u67e5\u64cd\u4f5c\u624b\u518a(IOM)<\/a>{:target=&#8221;_blank&#8221;},<strong>483 \u8868\u683c\u662f FDA \u6aa2\u67e5\u5b98\u5728\u6aa2\u67e5\u7d50\u675f\u6642,\u5411\u8a2d\u65bd\u7ba1\u7406\u5c64\u7576\u5834\u767c\u51fa\u7684\u66f8\u9762\u6587\u4ef6<\/strong>,\u5217\u51fa\u6aa2\u67e5\u671f\u9593\u300c\u53ef\u89c0\u5bdf\u5230\u7684\u7f3a\u5931\u300d(Objectionable Conditions)\u3002<\/p>\r\n<p><strong>\u6838\u5fc3\u7279\u6027<\/strong>:<\/p>\r\n<ul>\r\n<li><strong>\u5373\u6642\u6027<\/strong>:\u6aa2\u67e5\u7d50\u675f\u7576\u5929\u767c\u51fa,\u7ba1\u7406\u5c64\u9700\u7576\u5834\u7c3d\u6536<\/li>\r\n<li><strong>\u63cf\u8ff0\u6027<\/strong>:\u50c5\u63cf\u8ff0\u767c\u73fe\u7684\u7f3a\u5931,\u4e0d\u5305\u542b\u6cd5\u5f8b\u5224\u5b9a\u6216\u8655\u7f70<\/li>\r\n<li><strong>\u521d\u6b65\u6027<\/strong>:\u4e26\u975e\u6700\u7d42\u7d50\u8ad6,FDA \u4ecd\u9700\u9032\u4e00\u6b65\u8a55\u4f30<\/li>\r\n<\/ul>\r\n<h3>483 \u8868\u683c\u7684\u5e38\u898b\u7f3a\u5931\u985e\u578b<\/h3>\r\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\r\n<table>\r\n<thead>\r\n<tr>\r\n<th>\u7f3a\u5931\u985e\u5225<\/th>\r\n<th>\u5177\u9ad4\u7bc4\u4f8b<\/th>\r\n<th>\u56b4\u91cd\u7a0b\u5ea6<\/th>\r\n<\/tr>\r\n<\/thead>\r\n<tbody>\r\n<tr>\r\n<td>\u6587\u4ef6\u8a18\u9304\u4e0d\u5b8c\u6574<\/td>\r\n<td>\u98df\u54c1\u5b89\u5168\u8a08\u756b\u672a\u66f4\u65b0\u3001HACCP \u8a18\u9304\u7f3a\u6f0f<\/td>\r\n<td>\u4f4e-\u4e2d<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>\u885b\u751f\u689d\u4ef6\u4e0d\u4f73<\/td>\r\n<td>\u8a2d\u5099\u6e05\u6f54\u4e0d\u8db3\u3001\u4eba\u54e1\u885b\u751f\u7ba1\u7406\u7f3a\u5931<\/td>\r\n<td>center<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>\u88fd\u7a0b\u63a7\u5236\u554f\u984c<\/td>\r\n<td>\u6eab\u5ea6\u76e3\u63a7\u4e0d\u7576\u3001\u4ea4\u53c9\u6c61\u67d3\u98a8\u96aa<\/td>\r\n<td>\u4e2d-\u9ad8<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Labeling irregularities<\/td>\r\n<td>\u904e\u654f\u539f\u6a19\u793a\u932f\u8aa4\u3001\u71df\u990a\u6a19\u793a\u4e0d\u5b8c\u6574<\/td>\r\n<td>center<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/div>\r\n<h3>\u6536\u5230 483 \u8868\u683c\u5f8c\u8a72\u5982\u4f55\u61c9\u5c0d?<\/h3>\r\n<p><strong>\u5efa\u8b70\u56de\u61c9\u6642\u9593<\/strong>:15 \u500b\u5de5\u4f5c\u5929\u5167(\u975e\u5f37\u5236,\u4f46 FDA \u671f\u5f85)<\/p>\r\n<p><strong>\u6b63\u78ba\u61c9\u5c0d\u6b65\u9a5f<\/strong>:<\/p>\r\n<ol>\r\n<li><strong>\u7acb\u5373\u5167\u90e8\u6aa2\u8a0e<\/strong>:\u53ec\u96c6\u76f8\u95dc\u90e8\u9580\u78ba\u8a8d\u7f3a\u5931\u771f\u5be6\u6027<\/li>\r\n<li><strong>\u5236\u5b9a\u6539\u5584\u8a08\u756b<\/strong>:\u91dd\u5c0d\u6bcf\u9805\u7f3a\u5931\u63d0\u51fa\u5177\u9ad4\u6539\u5584\u63aa\u65bd<\/li>\r\n<li><strong>\u66f8\u9762\u56de\u8986 FDA<\/strong>:\u8aaa\u660e\u6539\u5584\u884c\u52d5\u3001\u5b8c\u6210\u6642\u9593\u8207\u9810\u9632\u63aa\u65bd<\/li>\r\n<li><strong>Keeping complete records<\/strong>:\u6240\u6709\u6539\u5584\u8b49\u64da\u9700\u7559\u5b58\u5099\u67e5<\/li>\r\n<\/ol>\r\n<p>\u26a0\ufe0f <strong>important reminder<\/strong>:\u5373\u4f7f 483 \u8868\u683c\u4e0d\u662f\u6b63\u5f0f\u8655\u7f70,\u82e5\u672a\u59a5\u5584\u56de\u61c9,FDA \u53ef\u80fd\u5347\u7d1a\u70ba\u8b66\u544a\u4fe1\u6216\u9032\u53e3\u6263\u7559\u3002<\/p>\r\n<h2>EIR(Establishment Inspection Report):\u5b8c\u6574\u6aa2\u67e5\u5831\u544a<\/h2>\r\n<h3>\u4ec0\u9ebc\u662f EIR?<\/h3>\r\n<p><strong>EIR \u662f FDA \u6aa2\u67e5\u5b98\u5b8c\u6210\u6aa2\u67e5\u5f8c,\u63d0\u4ea4\u7d66 FDA \u7e3d\u90e8\u7684\u5167\u90e8\u5831\u544a<\/strong>,\u8a18\u9304\u6aa2\u67e5\u7684\u5b8c\u6574\u904e\u7a0b\u3001\u767c\u73fe\u7684\u6240\u6709\u554f\u984c\u8207\u6aa2\u67e5\u5b98\u7684\u8a55\u4f30\u610f\u898b\u3002<\/p>\r\n<p><strong>\u6838\u5fc3\u7279\u6027<\/strong>:<\/p>\r\n<ul>\r\n<li><strong>\u5167\u90e8\u6587\u4ef6<\/strong>:\u4e3b\u8981\u4f9b FDA \u5167\u90e8\u4f7f\u7528,\u4e0d\u6703\u4e3b\u52d5\u767c\u7d66\u8a2d\u65bd<\/li>\r\n<li><strong>\u5168\u9762\u6027<\/strong>:\u5305\u542b\u6aa2\u67e5\u6642\u9593\u3001\u7bc4\u570d\u3001\u767c\u73fe\u554f\u984c\u3001\u6a23\u54c1\u63a1\u96c6\u7b49\u6240\u6709\u7d30\u7bc0<\/li>\r\n<li><strong>\u5206\u985e\u4f9d\u64da<\/strong>:FDA \u4f9d\u64da EIR \u5167\u5bb9,\u6c7a\u5b9a\u662f\u5426\u767c\u51fa\u8b66\u544a\u4fe1\u6216\u63a1\u53d6\u5176\u4ed6\u884c\u52d5<\/li>\r\n<\/ul>\r\n<h3>EIR \u7684\u4e09\u7a2e\u5206\u985e<\/h3>\r\n<p>rely on <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-20.64\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 20.64<\/a>{:target=&#8221;_blank&#8221;},EIR \u5206\u70ba\u4e09\u7a2e\u5206\u985e:<\/p>\r\n<ul>\r\n<li><strong>NAI(No Action Indicated)<\/strong>:\u7121\u9700\u63a1\u53d6\u884c\u52d5,\u8a2d\u65bd\u5408\u898f<\/li>\r\n<li><strong>VAI(Voluntary Action Indicated)<\/strong>:\u5efa\u8b70\u81ea\u9858\u6539\u5584,\u4f46\u7121\u5f37\u5236\u8981\u6c42<\/li>\r\n<li><strong>OAI(Official Action Indicated)<\/strong>:\u9700\u63a1\u53d6\u6b63\u5f0f\u884c\u52d5,\u53ef\u80fd\u767c\u8b66\u544a\u4fe1\u6216\u6263\u7559\u7522\u54c1<\/li>\r\n<\/ul>\r\n<h3>\u53f0\u7063\u696d\u8005\u80fd\u5426\u53d6\u5f97 EIR?<\/h3>\r\n<p><strong>\u53ef\u4ee5,\u4f46\u9700\u900f\u904e FOIA(\u8cc7\u8a0a\u81ea\u7531\u6cd5)\u7533\u8acb<\/strong>:<\/p>\r\n<ul>\r\n<li>\u7533\u8acb\u7db2\u5740:<a href=\"https:\/\/www.fda.gov\/regulatory-information\/freedom-information\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/regulatory-information\/freedom-information<\/a><\/li>\r\n<li>\u8655\u7406\u6642\u9593:\u901a\u5e38\u9700 20-60 \u500b\u5de5\u4f5c\u5929<\/li>\r\n<li>\u8cbb\u7528:\u4f9d\u6587\u4ef6\u9801\u6578\u6536\u8cbb(\u53ef\u80fd\u514d\u8cbb\u6216\u9700\u4ed8\u8cbb)<\/li>\r\n<\/ul>\r\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>:\u82e5\u6536\u5230 483 \u8868\u683c,\u5efa\u8b70\u540c\u6b65\u7533\u8acb EIR,\u4ee5\u4e86\u89e3 FDA \u7684\u5b8c\u6574\u8a55\u4f30\u610f\u898b\u3002<\/p>\r\n<h2>\u8b66\u544a\u4fe1(Warning Letter):\u6b63\u5f0f\u9055\u898f\u901a\u77e5<\/h2>\r\n<h3>\u4ec0\u9ebc\u662f\u8b66\u544a\u4fe1?<\/h3>\r\n<p>According to <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/warning-letters\" target=\"_blank\" rel=\"noopener\">FDA \u8b66\u544a\u4fe1\u5b98\u65b9\u8cc7\u6599\u5eab<\/a>{:target=&#8221;_blank&#8221;},<strong>\u8b66\u544a\u4fe1\u662f FDA \u767c\u51fa\u7684\u6b63\u5f0f\u6cd5\u898f\u9055\u898f\u901a\u77e5<\/strong>,\u8868\u793a\u8a2d\u65bd\u5b58\u5728\u56b4\u91cd\u7684\u4e0d\u5408\u898f\u554f\u984c,\u82e5\u672a\u6539\u5584\u5c07\u9762\u81e8\u6cd5\u5f8b\u884c\u52d5\u3002<\/p>\r\n<p><strong>\u6838\u5fc3\u7279\u6027<\/strong>:<\/p>\r\n<ul>\r\n<li><strong>\u6b63\u5f0f\u6027<\/strong>:\u7531 FDA \u5730\u5340\u8fa6\u516c\u5ba4\u4e3b\u7ba1\u6216\u7e3d\u90e8\u5b98\u54e1\u7c3d\u767c<\/li>\r\n<li><strong>\u516c\u958b\u6027<\/strong>:\u6240\u6709\u8b66\u544a\u4fe1\u6703\u516c\u958b\u65bc FDA \u5b98\u7db2,\u53ef\u88ab\u516c\u773e\u67e5\u8a62<\/li>\r\n<li><strong>mandatory<\/strong>:\u5fc5\u9808\u5728 15 \u500b\u5de5\u4f5c\u5929\u5167\u66f8\u9762\u56de\u8986\u6539\u5584\u8a08\u756b<\/li>\r\n<\/ul>\r\n<h3>\u8b66\u544a\u4fe1\u7684\u5e38\u898b\u9055\u898f\u985e\u578b<\/h3>\r\n<ul>\r\n<li><strong>CGMP \u9055\u898f<\/strong>:\u672a\u9075\u5b88\u73fe\u884c\u826f\u597d\u4f5c\u696d\u898f\u7bc4(Current Good Manufacturing Practice)<\/li>\r\n<li><strong>FSMA \u9055\u898f<\/strong>:\u672a\u5efa\u7acb\u9810\u9632\u6027\u63a7\u5236\u8a08\u756b\u3001HACCP \u7cfb\u7d71\u7f3a\u5931<\/li>\r\n<li><strong>\u647b\u5047\u6216\u6a19\u793a\u4e0d\u5be6<\/strong>:\u7522\u54c1\u542b\u6709\u672a\u7533\u5831\u6210\u5206\u3001\u6a19\u7c64\u8aa4\u5c0e\u6d88\u8cbb\u8005<\/li>\r\n<li><strong>\u672a\u8a3b\u518a\u6216\u672a\u901a\u5831<\/strong>:\u8a2d\u65bd\u672a\u5b8c\u6210 FDA \u8a3b\u518a\u3001\u7522\u54c1\u672a\u901a\u5831<\/li>\r\n<\/ul>\r\n<h3>\u6536\u5230\u8b66\u544a\u4fe1\u7684\u56b4\u91cd\u5f8c\u679c<\/h3>\r\n<ul>\r\n<li><strong>\u9032\u53e3\u6263\u7559<\/strong>:\u6240\u6709\u7522\u54c1\u53ef\u80fd\u88ab FDA \u81ea\u52d5\u6263\u7559(Import Alert)<\/li>\r\n<li><strong>Product Recall<\/strong>:FDA \u53ef\u8981\u6c42\u5f37\u5236\u53ec\u56de\u5df2\u4e0a\u5e02\u7522\u54c1<\/li>\r\n<li><strong>Legal proceedings<\/strong>:\u53ef\u80fd\u9762\u81e8\u6c11\u4e8b\u6216\u5211\u4e8b\u8a34\u8a1f<\/li>\r\n<li><strong>\u8072\u8b7d\u640d\u5bb3<\/strong>:\u8b66\u544a\u4fe1\u516c\u958b\u65bc\u5b98\u7db2,\u5f71\u97ff\u54c1\u724c\u5f62\u8c61<\/li>\r\n<\/ul>\r\n<hr \/>\r\n<h3>\u5716 3: FDA \u6aa2\u67e5\u5831\u544a\u61c9\u5c0d\u6d41\u7a0b\u5716<\/h3>\r\n<\/figure>\r\n<p>&nbsp;<\/p>\r\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20117\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-response-flowchart-form-483-eir-warning-letter-2026.png\" alt=\"FDA \u6aa2\u67e5\u5831\u544a\u61c9\u5c0d\u6d41\u7a0b\u5716,\u986f\u793a\u6536\u5230 483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u5f8c\u7684\u6b63\u78ba\u56de\u61c9\u6b65\u9a5f\u8207\u6642\u9593\u8981\u6c42\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-response-flowchart-form-483-eir-warning-letter-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-response-flowchart-form-483-eir-warning-letter-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-response-flowchart-form-483-eir-warning-letter-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-response-flowchart-form-483-eir-warning-letter-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/06\/fda-inspection-reports-response-flowchart-form-483-eir-warning-letter-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\r\n<figure class=\"wp-block-image size-full\"><hr \/>\r\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 4 \u500b\u91cd\u9ede<\/h2>\r\n<h3>1. 483 \u8868\u683c\u4e0d\u7b49\u65bc\u8b66\u544a\u4fe1,\u4f46\u53ef\u80fd\u5347\u7d1a<\/h3>\r\n<p><strong>Common Misconceptions<\/strong>:\u8a31\u591a\u53f0\u7063\u696d\u8005\u4ee5\u70ba\u6536\u5230 483 \u8868\u683c\u5c31\u4ee3\u8868\u56b4\u91cd\u9055\u898f,\u5176\u5be6 483 \u53ea\u662f\u521d\u6b65\u901a\u77e5\u3002\u4f46\u82e5\u672a\u59a5\u5584\u56de\u61c9,FDA \u53ef\u80fd\u5728\u5f8c\u7e8c\u8a55\u4f30\u5f8c\u5347\u7d1a\u70ba\u8b66\u544a\u4fe1\u3002<\/p>\r\n<h3>2. EIR \u5206\u985e\u6c7a\u5b9a\u5f8c\u7e8c\u884c\u52d5<\/h3>\r\n<p><strong>\u5be6\u52d9\u5224\u65b7<\/strong>:\u82e5 EIR \u88ab\u5206\u985e\u70ba OAI(Official Action Indicated),\u4ee3\u8868 FDA \u8a8d\u70ba\u9700\u63a1\u53d6\u6b63\u5f0f\u884c\u52d5,\u6b64\u6642\u61c9\u4e3b\u52d5\u806f\u7e6b FDA \u4e86\u89e3\u5177\u9ad4\u7591\u616e,\u907f\u514d\u76f4\u63a5\u6536\u5230\u8b66\u544a\u4fe1\u3002<\/p>\r\n<h3>3. \u8b66\u544a\u4fe1\u56de\u8986\u9700\u5c08\u696d\u5354\u52a9<\/h3>\r\n<p><strong>\u98a8\u96aa\u63d0\u9192<\/strong>:\u8b66\u544a\u4fe1\u7684\u56de\u8986\u5167\u5bb9\u6703\u6210\u70ba\u6cd5\u5f8b\u6587\u4ef6,<strong>\u5f37\u70c8\u5efa\u8b70\u7531\u719f\u6089 FDA \u6cd5\u898f\u7684\u5f8b\u5e2b\u6216\u9867\u554f\u5354\u52a9\u64b0\u5beb<\/strong>,\u907f\u514d\u56e0\u7528\u8a5e\u4e0d\u7576\u5c0e\u81f4\u66f4\u56b4\u91cd\u5f8c\u679c\u3002<\/p>\r\n<h3>4. \u6240\u6709\u6aa2\u67e5\u5831\u544a\u90fd\u6703\u5f71\u97ff\u98a8\u96aa\u8a55\u7d1a<\/h3>\r\n<p><strong>\u9577\u671f\u5f71\u97ff<\/strong>:\u5373\u4f7f\u6210\u529f\u56de\u61c9 483 \u8868\u683c\u6216\u8b66\u544a\u4fe1,FDA \u4ecd\u6703\u5c07\u6b64\u8a18\u9304\u7d0d\u5165\u8a2d\u65bd\u7684\u98a8\u96aa\u8a55\u7d1a,<strong>\u53ef\u80fd\u5c0e\u81f4\u672a\u4f86\u6aa2\u67e5\u983b\u7387\u589e\u52a0\u6216\u9032\u53e3\u5be9\u67e5\u66f4\u56b4\u683c<\/strong>The<\/p>\r\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3 FDA \u98df\u54c1\u8a3b\u518a\u7684\u6263\u95dc\u3001\u67e5\u9a57\u8207\u5e38\u898b\u932f\u8aa4,\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762,\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\r\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u98a8\u96aa\u89e3\u6790|\u6263\u95dc\u3001\u67e5\u9a57\u8207\u5e38\u898b\u932f\u8aa4\u6574\u7406(2026)<\/strong><br \/><a href=\"https:\/\/greenoo.tw\/en\/fda-food-registration-fda-food-registration-risks-and-inspections\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration-fda-food-registration-risks-and-inspections\/<\/a><\/p>\r\n<h2>Conclusion<\/h2>\r\n<ul>\r\n<li><strong>483 \u8868\u683c<\/strong>:\u6aa2\u67e5\u4e2d\u767c\u73fe\u7684\u53ef\u89c0\u5bdf\u7f3a\u5931,\u5efa\u8b70 15 \u5929\u5167\u56de\u8986,\u5c6c\u65bc\u521d\u6b65\u901a\u77e5<\/li>\r\n<li><strong>EIR<\/strong>:\u5b8c\u6574\u6aa2\u67e5\u5831\u544a,\u4f9b FDA \u5167\u90e8\u8a55\u4f30,\u53ef\u900f\u904e FOIA \u7533\u8acb\u53d6\u5f97<\/li>\r\n<li><strong>\u8b66\u544a\u4fe1<\/strong>:\u6b63\u5f0f\u9055\u898f\u901a\u77e5,\u5fc5\u9808 15 \u5929\u5167\u56de\u8986,\u672a\u6539\u5584\u5c07\u9762\u81e8\u6cd5\u5f8b\u884c\u52d5<\/li>\r\n<li><strong>\u6b63\u78ba\u61c9\u5c0d<\/strong>:\u6240\u6709\u6aa2\u67e5\u5831\u544a\u90fd\u61c9\u8a8d\u771f\u5c0d\u5f85,\u66f8\u9762\u56de\u8986\u524d\u5efa\u8b70\u8aee\u8a62\u5c08\u696d\u9867\u554f<\/li>\r\n<li><strong>\u9810\u9632\u70ba\u4e3b<\/strong>:\u5efa\u7acb\u5b8c\u5584\u7684\u98df\u54c1\u5b89\u5168\u8a08\u756b\u8207\u5167\u90e8\u7a3d\u6838\u6a5f\u5236,\u964d\u4f4e\u6aa2\u67e5\u98a8\u96aa<\/li>\r\n<\/ul>\r\n<p>\u82e5\u5c0d FDA \u98df\u54c1\u5408\u898f\u8207\u6aa2\u67e5\u61c9\u5c0d\u4ecd\u6709\u7591\u554f,\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/en\/\" target=\"_blank\" rel=\"noopener\">Green Circle Official Website<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\u3002<\/p>\r\n<hr \/>\r\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\r\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0b FDA \u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f3 2026 \u5e74 1 \u6708):<\/p>\r\n<ol>\r\n<li>U.S. Food and Drug Administration. &#8220;Inspection Guides.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides<\/a><\/li>\r\n<li>U.S. Food and Drug Administration. &#8220;Investigations Operations Manual (IOM).&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-references\/investigations-operations-manual\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-references\/investigations-operations-manual<\/a><\/li>\r\n<li>U.S. Food and Drug Administration. &#8220;Warning Letters.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/warning-letters\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/warning-letters<\/a><\/li>\r\n<li>Code of Federal Regulations Title 21, \u00a7 20.64. &#8220;Establishment Inspection Reports.&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-20.64\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/section-20.64<\/a><\/li>\r\n<\/ol>\r\n<p><em>\u8a3b:FDA \u6cd5\u898f\u53ef\u80fd\u66f4\u65b0,\u5efa\u8b70\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002<\/em><\/p>\r\n<\/figure>","protected":false},"excerpt":{"rendered":"","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":[46,45],"tags":[],"class_list":["post-9696","post","type-post","status-publish","format-standard","hentry","category-46","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/9696"}],"collection":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/comments?post=9696"}],"version-history":[{"count":4,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/9696\/revisions"}],"predecessor-version":[{"id":20118,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/9696\/revisions\/20118"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=9696"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=9696"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=9696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}