{"id":17005,"date":"2025-05-07T11:40:06","date_gmt":"2025-05-07T03:40:06","guid":{"rendered":"https:\/\/greenoo.tw\/?p=17005"},"modified":"2026-01-28T12:08:37","modified_gmt":"2026-01-28T04:08:37","slug":"fda-compliance-guide-483-form-eir-warning-letter-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/fda-compliance-guide-483-form-eir-warning-letter-2026\/","title":{"rendered":"\u7f8e\u570b FDA \u5408\u898f\u5168\u653b\u7565\uff1a483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u8a73\u89e3(2026 \u6700\u65b0)"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-20120\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-compliance-guide-483-eir-warning-letter-feature-2026.png\" alt=\"\u7f8e\u570b FDA \u5408\u898f\u5168\u653b\u7565\u5c01\u9762,\u986f\u793a 483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u6587\u4ef6\u5716\u6a19,2026 \u6700\u65b0\u5c08\u696d\u6307\u5357\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-compliance-guide-483-eir-warning-letter-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-compliance-guide-483-eir-warning-letter-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-compliance-guide-483-eir-warning-letter-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-compliance-guide-483-eir-warning-letter-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-compliance-guide-483-eir-warning-letter-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>FDA \u7a3d\u67e5\u6587\u4ef6\u662f\u4ec0\u9ebc?\u70ba\u4f55\u53f0\u7063\u696d\u8005\u9700\u8981\u4e86\u89e3?<\/h2>\n<p>According to <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides\" target=\"_blank\" rel=\"noopener\">FDA \u7a3d\u67e5\u7a0b\u5e8f\u898f\u5b9a<\/a>\u7576 FDA \u5c0d\u98df\u54c1\u8a2d\u65bd\u9032\u884c\u7a3d\u67e5\u6642,\u6703\u4f9d\u64da\u767c\u73fe\u7684\u7f3a\u5931\u56b4\u91cd\u7a0b\u5ea6,\u6838\u767c\u4e0d\u540c\u985e\u578b\u7684\u5b98\u65b9\u6587\u4ef6\u3002<strong>FDA 483 \u8868\u683c(Form 483)\u3001\u7a3d\u67e5\u5831\u544a(Establishment Inspection Report, EIR)\u8207\u8b66\u544a\u4fe1(Warning Letter)\u662f\u4e09\u7a2e\u6700\u5e38\u898b\u7684\u7a3d\u67e5\u7d50\u679c\u6587\u4ef6<\/strong>,\u76f4\u63a5\u5f71\u97ff\u53f0\u7063\u98df\u54c1\u696d\u8005\u7684\u51fa\u53e3\u8cc7\u683c\u8207\u5e02\u5834\u51c6\u5165\u3002<\/p>\n<p>\u7406\u89e3\u9019\u4e09\u7a2e\u6587\u4ef6\u7684\u5dee\u7570\u8207\u61c9\u5c0d\u7b56\u7565,\u80fd\u6709\u6548\u964d\u4f4e\u6263\u95dc\u98a8\u96aa\u3001\u907f\u514d\u7f70\u6b3e,\u4e26\u7dad\u8b77\u54c1\u724c\u8072\u8b7d\u3002\u7279\u5225\u662f\u5728 FSMA(\u98df\u54c1\u5b89\u5168\u73fe\u4ee3\u5316\u6cd5\u6848)\u5be6\u65bd\u5f8c,FDA \u7a3d\u67e5\u983b\u7387\u8207\u56b4\u683c\u5ea6\u5927\u5e45\u63d0\u5347,\u53f0\u7063\u696d\u8005\u5fc5\u9808\u5efa\u7acb\u5b8c\u6574\u7684\u5408\u898f\u61c9\u5c0d\u6a5f\u5236\u3002<\/p>\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>\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 \/>\n<a href=\"https:\/\/greenoo.tw\/en\/fda-food-registration\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration\/<\/a><\/p>\n<hr \/>\n<h2>FDA 483 \u8868\u683c:\u7a3d\u67e5\u7f3a\u5931\u7684\u6b63\u5f0f\u901a\u77e5<\/h2>\n<h3>\u4ec0\u9ebc\u662f FDA 483 \u8868\u683c?<\/h3>\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>,<strong>FDA 483 \u8868\u683c\u662f\u7a3d\u67e5\u5b98\u5728\u73fe\u5834\u7a3d\u67e5\u7d50\u675f\u6642,\u5411\u8a2d\u65bd\u8ca0\u8cac\u4eba\u63d0\u4f9b\u7684\u66f8\u9762\u89c0\u5bdf\u5831\u544a<\/strong>,\u5217\u51fa\u6240\u6709\u767c\u73fe\u7684\u6f5b\u5728\u9055\u898f\u4e8b\u9805\u6216\u9700\u6539\u5584\u7684\u7f3a\u5931\u3002<\/p>\n<p><strong>\u6838\u5fc3\u7279\u5fb5<\/strong>:<\/p>\n<ul>\n<li>\u73fe\u5834\u5373\u6642\u6838\u767c(\u7a3d\u67e5\u7d50\u675f\u524d)<\/li>\n<li>\u5217\u51fa\u5177\u9ad4\u89c0\u5bdf\u5230\u7684\u7f3a\u5931(\u975e\u6700\u7d42\u5224\u5b9a)<\/li>\n<li>\u8a2d\u65bd\u6709 15 \u500b\u5de5\u4f5c\u65e5\u56de\u61c9\u671f\u9650<\/li>\n<li>\u4e0d\u4ee3\u8868 FDA \u6700\u7d42\u57f7\u6cd5\u884c\u52d5<\/li>\n<\/ul>\n<h3>\u5e38\u898b 483 \u8868\u683c\u7f3a\u5931\u985e\u578b<\/h3>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>\u7f3a\u5931\u985e\u578b<\/th>\n<th>\u5177\u9ad4\u7bc4\u4f8b<\/th>\n<th>Risk Level<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6587\u4ef6\u8a18\u9304\u4e0d\u5b8c\u6574<\/td>\n<td>\u98df\u54c1\u5b89\u5168\u8a08\u756b\u672a\u5b9a\u671f\u66f4\u65b0<\/td>\n<td>moderate<\/td>\n<\/tr>\n<tr>\n<td>\u74b0\u5883\u885b\u751f\u554f\u984c<\/td>\n<td>\u751f\u7522\u5340\u57df\u767c\u73fe\u87f2\u5bb3\u8de1\u8c61<\/td>\n<td>your (honorific)<\/td>\n<\/tr>\n<tr>\n<td>\u4eba\u54e1\u8a13\u7df4\u4e0d\u8db3<\/td>\n<td>\u54e1\u5de5\u672a\u63a5\u53d7\u904e\u654f\u539f\u7ba1\u7406\u8a13\u7df4<\/td>\n<td>moderate<\/td>\n<\/tr>\n<tr>\n<td>\u8a2d\u5099\u7dad\u8b77\u7f3a\u5931<\/td>\n<td>\u6eab\u5ea6\u76e3\u63a7\u8a2d\u5099\u672a\u6821\u6b63<\/td>\n<td>your (honorific)<\/td>\n<\/tr>\n<tr>\n<td>Labeling irregularities<\/td>\n<td>\u904e\u654f\u539f\u6a19\u793a\u907a\u6f0f\u6216\u932f\u8aa4<\/td>\n<td>your (honorific)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h3>\u6536\u5230 483 \u8868\u683c\u5f8c\u7684\u6b63\u78ba\u61c9\u5c0d<\/h3>\n<p><strong>\u6b65\u9a5f 1: \u7acb\u5373\u7d44\u6210\u5167\u90e8\u61c9\u5c0d\u5c0f\u7d44<\/strong>(1-2 \u5929\u5167)<\/p>\n<ul>\n<li>\u6307\u5b9a\u5c08\u8cac\u4eba\u54e1\u7d71\u7c4c\u56de\u61c9<\/li>\n<li>\u53ec\u96c6\u54c1\u4fdd\u3001\u751f\u7522\u3001\u6cd5\u52d9\u90e8\u9580<\/li>\n<li>\u5efa\u7acb\u7f3a\u5931\u6539\u5584\u6642\u7a0b\u8868<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f 2: \u8a73\u7d30\u5206\u6790\u6bcf\u9805\u7f3a\u5931<\/strong>(3-5 \u5929\u5167)<\/p>\n<ul>\n<li>\u78ba\u8a8d\u7f3a\u5931\u7684\u6839\u672c\u539f\u56e0<\/li>\n<li>\u8a55\u4f30\u6539\u5584\u6240\u9700\u8cc7\u6e90\u8207\u6642\u9593<\/li>\n<li>\u512a\u5148\u8655\u7406\u9ad8\u98a8\u96aa\u9805\u76ee<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f 3: \u63d0\u4ea4\u66f8\u9762\u56de\u61c9\u7d66 FDA<\/strong>(15 \u500b\u5de5\u4f5c\u65e5\u5167)<\/p>\n<ul>\n<li>\u8aaa\u660e\u6bcf\u9805\u7f3a\u5931\u7684\u6539\u5584\u63aa\u65bd<\/li>\n<li>\u63d0\u4f9b\u6539\u5584\u5b8c\u6210\u6642\u7a0b<\/li>\n<li>\u9644\u4e0a\u76f8\u95dc\u8b49\u660e\u6587\u4ef6(\u7167\u7247\u3001SOP \u4fee\u8a02\u7248\u7b49)<\/li>\n<\/ul>\n<p>\u26a0\ufe0f <strong>important reminder<\/strong>: \u672a\u5728\u671f\u9650\u5167\u56de\u61c9\u6216\u56de\u61c9\u4e0d\u5b8c\u6574,\u53ef\u80fd\u5c0e\u81f4 FDA \u5347\u7d1a\u70ba\u8b66\u544a\u4fe1\u6216\u9032\u53e3\u8b66\u793a,\u56b4\u91cd\u5f71\u97ff\u51fa\u53e3\u696d\u52d9\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: FDA 483 \u8868\u683c\u61c9\u5c0d\u6d41\u7a0b\u5716<\/h3>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20121\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-483-form-response-process-flowchart-2026.png\" alt=\"FDA 483 \u8868\u683c\u61c9\u5c0d\u6d41\u7a0b\u5716,\u986f\u793a\u5f9e\u6536\u5230\u8868\u683c\u5230\u57f7\u884c\u6539\u5584\u7684 6 \u500b\u6b65\u9a5f,\u5305\u542b\u6642\u9593\u7bc0\u9ede\u8207\u671f\u9650\u8aaa\u660e\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-483-form-response-process-flowchart-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-483-form-response-process-flowchart-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-483-form-response-process-flowchart-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-483-form-response-process-flowchart-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-483-form-response-process-flowchart-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<hr \/>\n<h2>EIR \u7a3d\u67e5\u5831\u544a:FDA \u7684\u5b8c\u6574\u8a55\u4f30\u7d50\u8ad6<\/h2>\n<h3>\u4ec0\u9ebc\u662f EIR?<\/h3>\n<p><strong>\u7a3d\u67e5\u5831\u544a(Establishment Inspection Report, EIR)\u662f FDA \u7a3d\u67e5\u5b98\u5b8c\u6210\u73fe\u5834\u7a3d\u67e5\u5f8c,\u63d0\u4ea4\u7d66 FDA \u7e3d\u90e8\u7684\u5b8c\u6574\u8a55\u4f30\u6587\u4ef6<\/strong>,\u8a18\u9304\u7a3d\u67e5\u904e\u7a0b\u3001\u767c\u73fe\u7684\u554f\u984c\u8207\u521d\u6b65\u7d50\u8ad6\u3002<\/p>\n<p><strong>EIR \u8207 483 \u8868\u683c\u7684\u5dee\u7570<\/strong>:<\/p>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>Project<\/th>\n<th>FDA 483 \u8868\u683c<\/th>\n<th>EIR \u7a3d\u67e5\u5831\u544a<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6838\u767c\u6642\u9593<\/td>\n<td>\u7a3d\u67e5\u7d50\u675f\u6642\u73fe\u5834\u4ea4\u4ed8<\/td>\n<td>\u7a3d\u67e5\u5f8c\u6578\u9031\u81f3\u6578\u6708<\/td>\n<\/tr>\n<tr>\n<td>\u63a5\u6536\u5c0d\u8c61<\/td>\n<td>\u8a2d\u65bd\u8ca0\u8cac\u4eba<\/td>\n<td>FDA \u5167\u90e8\u4f7f\u7528<\/td>\n<\/tr>\n<tr>\n<td>\u5167\u5bb9\u7bc4\u570d<\/td>\n<td>\u50c5\u5217\u51fa\u89c0\u5bdf\u5230\u7684\u7f3a\u5931<\/td>\n<td>\u5b8c\u6574\u7a3d\u67e5\u904e\u7a0b\u8207\u8a55\u4f30<\/td>\n<\/tr>\n<tr>\n<td>\u516c\u958b\u6027<\/td>\n<td>\u53ef\u900f\u904e FOIA \u7533\u8acb\u53d6\u5f97<\/td>\n<td>\u53ef\u900f\u904e FOIA \u7533\u8acb\u53d6\u5f97<\/td>\n<\/tr>\n<tr>\n<td>\u5f8c\u7e8c\u5f71\u97ff<\/td>\n<td>\u9700\u5728 15 \u5929\u5167\u56de\u61c9<\/td>\n<td>\u4f5c\u70ba\u57f7\u6cd5\u884c\u52d5\u4f9d\u64da<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h3>EIR \u7684\u4e09\u7a2e\u5206\u985e\u7d50\u679c<\/h3>\n<p>According to <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-classification-database\" target=\"_blank\" rel=\"noopener\">FDA \u7a3d\u67e5\u5206\u985e\u7cfb\u7d71<\/a>EIR \u6703\u7d66\u4e88\u4ee5\u4e0b\u4e09\u7a2e\u5206\u985e:<\/p>\n<p><strong>NAI(No Action Indicated)\u7121\u9700\u63a1\u53d6\u884c\u52d5<\/strong><\/p>\n<ul>\n<li>\u672a\u767c\u73fe\u9055\u898f\u6216\u50c5\u6709\u8f15\u5fae\u7f3a\u5931<\/li>\n<li>\u4e0d\u5f71\u97ff\u7522\u54c1\u5b89\u5168\u8207\u5408\u898f\u6027<\/li>\n<li>\u7121\u9700\u5f8c\u7e8c\u57f7\u6cd5\u884c\u52d5<\/li>\n<\/ul>\n<p><strong>VAI(Voluntary Action Indicated)\u5efa\u8b70\u81ea\u9858\u6539\u5584<\/strong><\/p>\n<ul>\n<li>\u767c\u73fe\u9700\u6539\u5584\u7684\u7f3a\u5931,\u4f46\u672a\u9054\u56b4\u91cd\u7a0b\u5ea6<\/li>\n<li>\u8a2d\u65bd\u61c9\u81ea\u884c\u6539\u5584,\u4f46 FDA \u4e0d\u6703\u5f37\u5236\u57f7\u6cd5<\/li>\n<li>\u53ef\u80fd\u9032\u884c\u5f8c\u7e8c\u8ffd\u8e64\u7a3d\u67e5<\/li>\n<\/ul>\n<p><strong>OAI(Official Action Indicated)\u9700\u63a1\u53d6\u5b98\u65b9\u884c\u52d5<\/strong><\/p>\n<ul>\n<li>\u767c\u73fe\u56b4\u91cd\u9055\u898f,\u9700 FDA \u6b63\u5f0f\u4ecb\u5165<\/li>\n<li>\u53ef\u80fd\u5c0e\u81f4\u8b66\u544a\u4fe1\u3001\u9032\u53e3\u8b66\u793a\u6216\u7522\u54c1\u6263\u62bc<\/li>\n<li>\u5fc5\u9808\u7acb\u5373\u6539\u5584\u4e26\u63d0\u4f9b\u8b49\u660e<\/li>\n<\/ul>\n<hr \/>\n<h2>\u8b66\u544a\u4fe1:FDA \u7684\u6b63\u5f0f\u57f7\u6cd5\u901a\u77e5<\/h2>\n<h3>\u4ec0\u9ebc\u662f\u8b66\u544a\u4fe1?<\/h3>\n<p>rely on <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\u653f\u7b56<\/a><strong>\u8b66\u544a\u4fe1(Warning Letter)\u662f FDA \u91dd\u5c0d\u56b4\u91cd\u9055\u898f\u884c\u70ba\u767c\u51fa\u7684\u6b63\u5f0f\u57f7\u6cd5\u6587\u4ef6<\/strong>,\u8981\u6c42\u8a2d\u65bd\u7acb\u5373\u6539\u5584,\u5426\u5247\u5c07\u9762\u81e8\u66f4\u56b4\u53b2\u7684\u6cd5\u5f8b\u884c\u52d5\u3002<\/p>\n<p><strong>\u8b66\u544a\u4fe1\u7684\u56b4\u91cd\u5f8c\u679c<\/strong>:<\/p>\n<ul>\n<li>\u7522\u54c1\u53ef\u80fd\u88ab\u6263\u62bc\u6216\u53ec\u56de<\/li>\n<li>\u9032\u53e3\u8ca8\u7269\u906d\u6d77\u95dc\u6263\u7559<\/li>\n<li>\u9762\u81e8\u6c11\u4e8b\u6216\u5211\u4e8b\u7f70\u6b3e<\/li>\n<li>\u516c\u53f8\u540d\u7a31\u516c\u958b\u65bc FDA \u7db2\u7ad9<\/li>\n<li>\u56b4\u91cd\u640d\u5bb3\u54c1\u724c\u8072\u8b7d<\/li>\n<\/ul>\n<h3>\u6536\u5230\u8b66\u544a\u4fe1\u5f8c\u7684\u61c9\u5c0d\u7b56\u7565<\/h3>\n<p><strong>\u7acb\u5373\u884c\u52d5(\u6536\u5230\u5f8c 15 \u5929\u5167)<\/strong>:<\/p>\n<ol>\n<li>\u505c\u6b62\u76f8\u95dc\u9055\u898f\u884c\u70ba<\/li>\n<li>\u8058\u8acb\u5c08\u696d\u6cd5\u898f\u9867\u554f\u5354\u52a9<\/li>\n<li>\u63d0\u4ea4\u8a73\u7d30\u7684\u6539\u5584\u8a08\u756b(CAPA, Corrective and Preventive Action)<\/li>\n<li>\u8aaa\u660e\u5df2\u63a1\u53d6\u7684\u7acb\u5373\u63aa\u65bd<\/li>\n<\/ol>\n<p><strong>\u9577\u671f\u6539\u5584(\u5f8c\u7e8c 30-90 \u5929)<\/strong>:<\/p>\n<ol>\n<li>\u5168\u9762\u6aa2\u8996\u8a2d\u65bd\u5408\u898f\u72c0\u614b<\/li>\n<li>\u66f4\u65b0 SOP \u8207\u54e1\u5de5\u8a13\u7df4<\/li>\n<li>\u5efa\u7acb\u5167\u90e8\u7a3d\u6838\u6a5f\u5236<\/li>\n<li>\u5b9a\u671f\u5411 FDA \u5831\u544a\u6539\u5584\u9032\u5ea6<\/li>\n<\/ol>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>: \u8b66\u544a\u4fe1\u56de\u61c9\u54c1\u8cea\u76f4\u63a5\u5f71\u97ff FDA \u5f8c\u7e8c\u57f7\u6cd5\u6c7a\u5b9a,\u5efa\u8b70\u5c0b\u6c42\u5c08\u696d\u9867\u554f\u5354\u52a9\u64b0\u5beb,\u907f\u514d\u56e0\u56de\u61c9\u4e0d\u7576\u5c0e\u81f4\u66f4\u56b4\u91cd\u5f8c\u679c\u3002<\/p>\n<hr \/>\n<h3>\u5716 3: FDA \u7a3d\u67e5\u6587\u4ef6\u56b4\u91cd\u7a0b\u5ea6\u5c0d\u7167\u8868<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20122\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-inspection-document-severity-comparison-table-2026.png\" alt=\"FDA \u7a3d\u67e5\u6587\u4ef6\u56b4\u91cd\u7a0b\u5ea6\u5c0d\u7167\u8868,\u986f\u793a 483 \u8868\u683c\u3001EIR \u8207\u8b66\u544a\u4fe1\u7684\u98a8\u96aa\u7b49\u7d1a\u3001\u56de\u61c9\u671f\u9650\u8207\u61c9\u5c0d\u7b56\u7565\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-inspection-document-severity-comparison-table-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-inspection-document-severity-comparison-table-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-inspection-document-severity-comparison-table-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-inspection-document-severity-comparison-table-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-inspection-document-severity-comparison-table-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<h2>\u5982\u4f55\u9810\u9632 FDA \u7a3d\u67e5\u7f3a\u5931?<\/h2>\n<p><strong>\u5efa\u7acb\u5b8c\u5584\u7684\u5167\u90e8\u7a3d\u6838\u6a5f\u5236<\/strong>:<\/p>\n<ul>\n<li>\u6bcf\u5b63\u9032\u884c\u81ea\u6211\u7a3d\u6838,\u6a21\u64ec FDA \u7a3d\u67e5\u6d41\u7a0b<\/li>\n<li>\u5efa\u7acb\u7f3a\u5931\u8ffd\u8e64\u7cfb\u7d71,\u78ba\u4fdd\u6539\u5584\u63aa\u65bd\u843d\u5be6<\/li>\n<li>\u5b9a\u671f\u66f4\u65b0 SOP,\u7b26\u5408\u6700\u65b0 FDA \u6cd5\u898f<\/li>\n<\/ul>\n<p><strong>\u52a0\u5f37\u54e1\u5de5\u8a13\u7df4\u8207\u6587\u4ef6\u7ba1\u7406<\/strong>:<\/p>\n<ul>\n<li>\u6240\u6709\u54e1\u5de5\u5fc5\u9808\u63a5\u53d7 GMP(\u826f\u597d\u4f5c\u696d\u898f\u7bc4)\u8a13\u7df4<\/li>\n<li>\u5efa\u7acb\u5b8c\u6574\u7684\u6587\u4ef6\u8a18\u9304\u7cfb\u7d71(\u96fb\u5b50\u5316\u512a\u5148)<\/li>\n<li>\u78ba\u4fdd\u904e\u654f\u539f\u7ba1\u7406\u8207\u6a19\u7c64\u5408\u898f<\/li>\n<\/ul>\n<p><strong>\u5c0b\u6c42\u5c08\u696d\u9867\u554f\u5354\u52a9<\/strong>:<\/p>\n<ul>\n<li>\u5b9a\u671f\u8aee\u8a62 FDA \u6cd5\u898f\u5c08\u5bb6<\/li>\n<li>\u5728\u7a3d\u67e5\u524d\u9032\u884c\u9810\u5be9(Pre-Audit)<\/li>\n<li>\u5efa\u7acb\u7dca\u6025\u61c9\u5c0d SOP<\/li>\n<\/ul>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3 FDA \u98df\u54c1\u8a3b\u518a\u7684\u98a8\u96aa\u8207\u67e5\u9a57\u7d30\u7bc0,\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762,\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\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 \/>\n<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>\n<hr \/>\n<h2>Conclusion<\/h2>\n<ul>\n<li><strong>FDA 483 \u8868\u683c<\/strong>\u662f\u7a3d\u67e5\u73fe\u5834\u6838\u767c\u7684\u7f3a\u5931\u901a\u77e5,\u5fc5\u9808\u5728 15 \u500b\u5de5\u4f5c\u65e5\u5167\u63d0\u4ea4\u66f8\u9762\u56de\u61c9<\/li>\n<li><strong>EIR \u7a3d\u67e5\u5831\u544a<\/strong>\u662f FDA \u5167\u90e8\u8a55\u4f30\u6587\u4ef6,\u5206\u70ba NAI\u3001VAI\u3001OAI \u4e09\u7a2e\u7b49\u7d1a<\/li>\n<li><strong>\u8b66\u544a\u4fe1<\/strong>\u662f\u6700\u56b4\u91cd\u7684\u57f7\u6cd5\u6587\u4ef6,\u53ef\u80fd\u5c0e\u81f4\u6263\u95dc\u3001\u7f70\u6b3e\u8207\u7522\u54c1\u53ec\u56de<\/li>\n<li>\u6536\u5230\u4efb\u4f55 FDA \u7a3d\u67e5\u6587\u4ef6\u90fd\u61c9\u7acb\u5373\u7d44\u6210\u61c9\u5c0d\u5c0f\u7d44,\u4e26\u5c0b\u6c42\u5c08\u696d\u9867\u554f\u5354\u52a9<\/li>\n<li>\u9810\u9632\u52dd\u65bc\u6cbb\u7642:\u5efa\u7acb\u5b8c\u5584\u7684\u5167\u90e8\u7a3d\u6838\u6a5f\u5236\u8207\u54e1\u5de5\u8a13\u7df4,\u964d\u4f4e\u7a3d\u67e5\u98a8\u96aa<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u98df\u54c1\u5408\u898f\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>\n<hr \/>\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0b FDA \u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f3 2026 \u5e74 1 \u6708):<\/p>\n<ol>\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>\n<li>Code of Federal Regulations Title 21, \u00a7 20.64. &#8220;Establishment Inspection Report.&#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>\n<li>U.S. Food and Drug Administration. &#8220;Inspection Classification Database.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-classification-database\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-classification-database<\/a><\/li>\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>\n<\/ol>\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>","protected":false},"excerpt":{"rendered":"<p>FDA \u7a3d\u67e5\u6587\u4ef6\u662f\u4ec0\u9ebc?\u70ba\u4f55\u53f0\u7063\u696d\u8005\u9700\u8981\u4e86\u89e3? \u6839\u64da FDA \u7a3d\u67e5\u7a0b\u5e8f\u898f\u5b9a\u7576 FDA \u5c0d\u98df\u54c1\u8a2d\u65bd\u9032\u884c\u7a3d\u67e5\u6642,\u6703 [&hellip;]<\/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-17005","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/17005"}],"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=17005"}],"version-history":[{"count":3,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/17005\/revisions"}],"predecessor-version":[{"id":20123,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/17005\/revisions\/20123"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=17005"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=17005"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=17005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}