{"id":9787,"date":"2025-11-03T09:00:00","date_gmt":"2025-11-03T09:00:00","guid":{"rendered":"https:\/\/aroundthe-world.net\/web\/?p=9787"},"modified":"2025-11-01T14:36:20","modified_gmt":"2025-11-01T14:36:20","slug":"inspection","status":"publish","type":"post","link":"https:\/\/aroundthe-world.net\/web\/2025\/11\/03\/inspection\/","title":{"rendered":"FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09\u306e\u5bfe\u7b56\u3068\u6e96\u5099\uff5c\u7a81\u7136\u306e\u67fb\u5bdf\u306b\u3082\u614c\u3066\u306a\u3044\u305f\u3081\u306b"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u30a2\u30e1\u30ea\u30ab\u3078\u98df\u54c1\u3084\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u5316\u7ca7\u54c1\u306a\u3069\u3092\u8f38\u51fa\u3057\u3066\u3044\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u3001<br>\u907f\u3051\u3066\u901a\u308c\u306a\u3044\u306e\u304c\u300c<strong>FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09<\/strong>\u300d\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u300c\u3046\u3061\u306b\u3082\u3044\u3064\u6765\u308b\u306e\u3060\u308d\u3046\uff1f\u300d<br>\u300c\u4f55\u3092\u6e96\u5099\u3057\u3066\u304a\u3051\u3070\u3044\u3044\u306e\u304b\u5206\u304b\u3089\u306a\u3044\u2026\u300d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u3093\u306a\u4e0d\u5b89\u3092\u62b1\u3048\u308b\u62c5\u5f53\u8005\u306f\u5c11\u306a\u304f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u4eca\u56de\u306f\u3001FDA\u67fb\u5bdf\u306e\u57fa\u672c\u3068\u3001<strong>\u5b9f\u969b\u306b\u5f79\u7acb\u3064\u5bfe\u7b56\u30fb\u6e96\u5099\u306e\u30dd\u30a4\u30f3\u30c8<\/strong>\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">? FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\u3068\u306f\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\uff08Food and Drug Administration\uff1a\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306f\u3001<br>\u30a2\u30e1\u30ea\u30ab\u56fd\u5185\u5916\u306e<strong>\u98df\u54c1\u30fb\u533b\u85ac\u54c1\u30fb\u5316\u7ca7\u54c1\u30fb\u533b\u7642\u6a5f\u5668<\/strong>\u306e\u5b89\u5168\u6027\u3092\u76e3\u7763\u3059\u308b\u6a5f\u95a2\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\u3068\u306f\u3001\u305d\u306eFDA\u304c\u884c\u3046<strong>\u88fd\u9020\u65bd\u8a2d\u30fb\u8f38\u51fa\u696d\u8005\u306a\u3069\u3078\u306e\u67fb\u5bdf<\/strong>\u306e\u3053\u3068\u3002<br>\u76ee\u7684\u306f\u3001\u4f01\u696d\u304cFDA\u306e\u898f\u5236\uff08\u4f8b\uff1a<strong>cGMP = Current Good Manufacturing Practice<\/strong>\uff09\u306b<br><strong>\u9069\u5207\u306b\u5f93\u3063\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068<\/strong>\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">? \u67fb\u5bdf\u306e\u5bfe\u8c61\u306b\u306a\u308b\u4f01\u696d<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u306e\u67fb\u5bdf\u5bfe\u8c61\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u4e8b\u696d\u8005\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30a2\u30e1\u30ea\u30ab\u3078<strong>\u98df\u54c1\u30fb\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u8f38\u51fa<\/strong>\u3057\u3066\u3044\u308b\u88fd\u9020\u696d\u8005<\/li>\n\n\n\n<li>FDA\u65bd\u8a2d\u767b\u9332\uff08FDA Establishment Registration\uff09\u3092\u3057\u3066\u3044\u308b\u5de5\u5834<\/li>\n\n\n\n<li>\u30a2\u30e1\u30ea\u30ab\u5e02\u5834\u5411\u3051\u306e<strong>OEM\u30e1\u30fc\u30ab\u30fc<\/strong>\u3084<strong>\u539f\u6750\u6599\u4f9b\u7d66\u696d\u8005<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u7279\u306b\u3001<strong>\u904e\u53bb\u306b\u9055\u53cd\u6b74\u304c\u3042\u308b\u4f01\u696d<\/strong>\u3084<strong>\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u88fd\u54c1\u3092\u6271\u3046\u65bd\u8a2d<\/strong>\u306f\u3001\u512a\u5148\u7684\u306b\u67fb\u5bdf\u5bfe\u8c61\u306b\u306a\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">? \u67fb\u5bdf\u306e\u7a2e\u985e<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u67fb\u5bdf\u306b\u306f\u5927\u304d\u304f\u5206\u3051\u30663\u3064\u306e\u30bf\u30a4\u30d7\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u67fb\u5bdf\u306e\u7a2e\u985e<\/th><th>\u5185\u5bb9<\/th><th>\u4e88\u544a\u306e\u6709\u7121<\/th><\/tr><\/thead><tbody><tr><td><strong>Routine Inspection\uff08\u5b9a\u671f\u67fb\u5bdf\uff09<\/strong><\/td><td>\u5b9a\u671f\u7684\u306b\u884c\u308f\u308c\u308b\u901a\u5e38\u67fb\u5bdf<\/td><td>\u901a\u5e38\u306f<strong>\u4e8b\u524d\u901a\u77e5\u3042\u308a<\/strong><\/td><\/tr><tr><td><strong>For Cause Inspection\uff08\u539f\u56e0\u8abf\u67fb\u67fb\u5bdf\uff09<\/strong><\/td><td>\u82e6\u60c5\u3084\u4e8b\u6545\u5831\u544a\u306a\u3069\u3001\u7279\u5b9a\u306e\u554f\u984c\u306b\u5bfe\u3057\u3066\u884c\u308f\u308c\u308b\u67fb\u5bdf<\/td><td>\u591a\u304f\u306e\u5834\u5408<strong>\u4e88\u544a\u306a\u3057<\/strong><\/td><\/tr><tr><td><strong>Follow-up Inspection\uff08\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u67fb\u5bdf\uff09<\/strong><\/td><td>\u904e\u53bb\u306e\u9055\u53cd\u662f\u6b63\u5f8c\u306e\u78ba\u8a8d<\/td><td><strong>\u4e8b\u524d\u901a\u77e5\u3042\u308a\uff0f\u306a\u3057\u4e21\u65b9\u3042\u308a<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u3064\u307e\u308a\u3001\u3044\u3064FDA\u304b\u3089\u9023\u7d61\u304c\u6765\u3066\u3082\u614c\u3066\u306a\u3044\u3088\u3046\u306b\u3001<br><strong>\u5e38\u306b\u67fb\u5bdf\u5bfe\u5fdc\u306e\u6e96\u5099\u3092\u6574\u3048\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981<\/strong>\u306a\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">? \u67fb\u5bdf\u306e\u6d41\u308c<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u67fb\u5bdf\u306e\u4e00\u822c\u7684\u306a\u6d41\u308c\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u4e8b\u524d\u901a\u77e5\uff08Notice of Inspection\uff09\u307e\u305f\u306f\u7a81\u7136\u306e\u8a2a\u554f<\/strong><\/li>\n\n\n\n<li>Form 482\uff08\u67fb\u5bdf\u958b\u59cb\u901a\u77e5\u66f8\uff09\u306e\u63d0\u793a<\/li>\n\n\n\n<li><strong>\u65bd\u8a2d\u306e\u898b\u5b66\u30fb\u88fd\u9020\u30e9\u30a4\u30f3\u306e\u78ba\u8a8d<\/strong><\/li>\n\n\n\n<li><strong>\u54c1\u8cea\u7ba1\u7406\u30fb\u8a18\u9332\u66f8\u985e\u306e\u78ba\u8a8d\uff08SOP\u30fb\u30ed\u30c3\u30c8\u8a18\u9332\u306a\u3069\uff09<\/strong><\/li>\n\n\n\n<li><strong>\u62c5\u5f53\u8005\u3078\u306e\u30a4\u30f3\u30bf\u30d3\u30e5\u30fc\u30fb\u8cea\u554f<\/strong><\/li>\n\n\n\n<li><strong>Form 483\uff08\u6307\u6458\u4e8b\u9805\u30ea\u30b9\u30c8\uff09\u306e\u4ea4\u4ed8<\/strong><\/li>\n\n\n\n<li><strong>\u662f\u6b63\u5831\u544a\u66f8\uff08CAPA\uff09\u306e\u63d0\u51fa<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u67fb\u5bdf\u306e\u7d50\u679c\u3001\u554f\u984c\u304c\u306a\u3051\u308c\u3070\u300cNo Action Indicated\uff08NAI\uff09\u300d\u3001<br>\u8efd\u5fae\u306a\u6307\u6458\u304c\u3042\u308c\u3070\u300cVoluntary Action Indicated\uff08VAI\uff09\u300d\u3001<br>\u91cd\u5927\u306a\u9055\u53cd\u304c\u3042\u308b\u5834\u5408\u306f\u300cOfficial Action Indicated\uff08OAI\uff09\u300d\u3068\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u26a0\ufe0f \u6307\u6458\u3055\u308c\u3084\u3059\u3044\u30dd\u30a4\u30f3\u30c8<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u67fb\u5bdf\u3067\u3088\u304f\u6307\u6458\u3055\u308c\u308b\u306e\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6587\u66f8\u7ba1\u7406\u306e\u4e0d\u5099<\/strong>\uff08\u8a18\u9332\u6f0f\u308c\u3001\u66f4\u65b0\u9045\u308c\uff09<\/li>\n\n\n\n<li><strong>\u885b\u751f\u7ba1\u7406\u30fb\u7570\u7269\u6df7\u5165\u9632\u6b62\u4f53\u5236\u306e\u4e0d\u5341\u5206\u3055<\/strong><\/li>\n\n\n\n<li><strong>\u6559\u80b2\u30fb\u8a13\u7df4\u8a18\u9332\u306e\u6b20\u843d<\/strong><\/li>\n\n\n\n<li><strong>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff08\u8ffd\u8de1\u6027\uff09\u306e\u6b20\u5982<\/strong><\/li>\n\n\n\n<li><strong>\u539f\u6750\u6599\u306e\u53d7\u5165\u691c\u67fb\u30fb\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406\u4e0d\u8db3<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u300c\u66f8\u3044\u3066\u3042\u308b\u3051\u3069\u904b\u7528\u3055\u308c\u3066\u3044\u306a\u3044\u300d\u30b1\u30fc\u30b9\u3082\u975e\u5e38\u306b\u591a\u304f\u3001<br>\u201c\u8a18\u9332\u3068\u5b9f\u614b\u306e\u6574\u5408\u6027\u201d\u304c\u91cd\u8996\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">? \u67fb\u5bdf\u5bfe\u7b56\u306e5\u3064\u306e\u6e96\u5099\u30dd\u30a4\u30f3\u30c8<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u2460 SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u306e\u6574\u5099<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u9020\u30fb\u6e05\u6383\u30fb\u691c\u67fb\u30fb\u51fa\u8377\u306a\u3069\u3001\u5168\u3066\u306e\u5de5\u7a0b\u306b\u3064\u3044\u3066<strong>SOP\u3092\u6700\u65b0\u7248\u306b\u66f4\u65b0<\/strong>\u3057\u3066\u304a\u304f\u3002<br>\u82f1\u8a9e\u7248\u3082\u4f75\u305b\u3066\u6e96\u5099\u3059\u308b\u3068\u30b9\u30e0\u30fc\u30ba\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2461 \u8a18\u9332\u66f8\u985e\u306e\u5373\u6642\u63d0\u793a<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u67fb\u5bdf\u5b98\u306f\u7a81\u7136\u300c\u3053\u306e\u30ed\u30c3\u30c8\u306e\u88fd\u9020\u8a18\u9332\u3092\u898b\u305b\u3066\u304f\u3060\u3055\u3044\u300d\u3068\u6c42\u3081\u307e\u3059\u3002<br>\u66f8\u985e\u304c\u3059\u3050\u306b\u51fa\u305b\u308b\u4f53\u5236\u3092\u6574\u3048\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2462 \u793e\u5185\u6559\u80b2\u30fb\u30e2\u30c3\u30af\u67fb\u5bdf\u306e\u5b9f\u65bd<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u73fe\u5834\u30b9\u30bf\u30c3\u30d5\u304c\u7a81\u7136\u8cea\u554f\u3055\u308c\u3066\u3082\u7b54\u3048\u3089\u308c\u308b\u3088\u3046\u3001\u6a21\u64ec\u67fb\u5bdf\uff08Mock Audit\uff09\u3092\u5b9a\u671f\u7684\u306b\u884c\u3046\u306e\u304c\u304a\u3059\u3059\u3081\u3002<br>\u300c\u8ab0\u304c\u3001\u4f55\u3092\u3001\u3069\u306e\u3088\u3046\u306b\u7b54\u3048\u308b\u304b\u300d\u3092\u3042\u3089\u304b\u3058\u3081\u6c7a\u3081\u3066\u304a\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2463 \u662f\u6b63\u63aa\u7f6e\uff08CAPA\uff09\u306e\u6e96\u5099<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u904e\u53bb\u306e\u30c8\u30e9\u30d6\u30eb\u3084\u30af\u30ec\u30fc\u30e0\u5bfe\u5fdc\u306b\u3064\u3044\u3066\u3001<strong>\u539f\u56e0\u5206\u6790\u3068\u518d\u767a\u9632\u6b62\u7b56<\/strong>\u3092\u6587\u66f8\u5316\u3057\u3066\u304a\u304f\u3002<br>FDA\u306f\u300c\u554f\u984c\u3092\u8d77\u3053\u3055\u306a\u3044\u7d44\u7e54\u300d\u3067\u306f\u306a\u304f\u3001\u300c\u554f\u984c\u3092\u6539\u5584\u3067\u304d\u308b\u7d44\u7e54\u300d\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2464 \u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u4f53\u5236\u306e\u660e\u78ba\u5316<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u67fb\u5bdf\u6642\u306b\u306f\u3001<strong>\u8ab0\u304cFDA\u5bfe\u5fdc\u306e\u7a93\u53e3\u306b\u306a\u308b\u304b<\/strong>\u3092\u4e8b\u524d\u306b\u6c7a\u3081\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<br>\u5168\u54e1\u304c\u52dd\u624b\u306b\u5bfe\u5fdc\u3059\u308b\u3068\u3001\u60c5\u5831\u306e\u98df\u3044\u9055\u3044\u304c\u8d77\u3053\u308a\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">?\ufe0f \u67fb\u5bdf\u5f8c\u306e\u5bfe\u5fdc<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u67fb\u5bdf\u304c\u7d42\u308f\u308b\u3068\u3001Form 483\uff08\u6307\u6458\u4e8b\u9805\uff09\u304c\u4ea4\u4ed8\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<br>\u6307\u6458\u3092\u53d7\u3051\u305f\u5834\u5408\u306f\u300115\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u662f\u6b63\u5831\u544a\u66f8\uff08CAPA\uff09\u3092\u63d0\u51fa\u3059\u308b\u306e\u304c\u539f\u5247\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u3068\u304d\u3001\u305f\u3060\u300c\u6539\u5584\u3057\u307e\u3057\u305f\u300d\u3068\u66f8\u304f\u306e\u3067\u306f\u306a\u304f\u3001<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4f55\u304c\u554f\u984c\u3060\u3063\u305f\u306e\u304b\uff08Root Cause\uff09<\/li>\n\n\n\n<li>\u3069\u3046\u6539\u5584\u3057\u305f\u306e\u304b\uff08Corrective Action\uff09<\/li>\n\n\n\n<li>\u518d\u767a\u9632\u6b62\u7b56\uff08Preventive Action\uff09<br>\u3092\u660e\u78ba\u306b\u8a18\u8f09\u3059\u308b\u3053\u3068\u304c\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">? \u307e\u3068\u3081\uff1aFDA\u67fb\u5bdf\u306f\u201c\u6016\u3044\u201d\u3082\u306e\u3067\u306f\u306a\u3044<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u67fb\u5bdf\u306f\u3001\u300c\u4f01\u696d\u306e\u4fe1\u983c\u6027\u300d\u3092\u793a\u3059\u30c1\u30e3\u30f3\u30b9\u3067\u3082\u3042\u308a\u307e\u3059\u3002<br>\u304d\u3061\u3093\u3068\u6e96\u5099\u3057\u3001\u900f\u660e\u6027\u306e\u3042\u308b\u904b\u55b6\u3092\u3057\u3066\u3044\u308c\u3070\u3001\u3080\u3057\u308d<strong>\u7c73\u56fd\u30d3\u30b8\u30cd\u30b9\u306e\u4fe1\u7528\u5411\u4e0a<\/strong>\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u67fb\u5bdf\u306f\u7a81\u7136\u3084\u3063\u3066\u304f\u308b\u304c\u3001\u6e96\u5099\u306f\u3044\u3064\u3067\u3082\u3067\u304d\u308b\u3002<\/strong><br>\u3053\u306e\u59ff\u52e2\u304c\u3001\u6d77\u5916\u5c55\u958b\u6210\u529f\u306e\u9375\u306b\u306a\u308b\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed\"><div class=\"wp-block-embed__wrapper\">\n<div class='avia-iframe-wrap'><blockquote class=\"wp-embedded-content\" data-secret=\"RYjRDmEYOx\"><a href=\"https:\/\/aroundthe-world.net\/web\/2025\/02\/10\/aboutus\/\">\u6d77\u5916\u5c55\u958b\u3068\u500b\u4eba\u30b5\u30dd\u30fc\u30c8\u306e\u4e21\u65b9\u3092\u5b8c\u74a7\u306b\u30ab\u30d0\u30fc\uff01\u696d\u754c\u5c48\u6307\u306e3PL\u30b5\u30fc\u30d3\u30b9<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;\u6d77\u5916\u5c55\u958b\u3068\u500b\u4eba\u30b5\u30dd\u30fc\u30c8\u306e\u4e21\u65b9\u3092\u5b8c\u74a7\u306b\u30ab\u30d0\u30fc\uff01\u696d\u754c\u5c48\u6307\u306e3PL\u30b5\u30fc\u30d3\u30b9&#8221; &#8212; Around The World Trading\" src=\"https:\/\/aroundthe-world.net\/web\/2025\/02\/10\/aboutus\/embed\/#?secret=kmgQpWDYF7#?secret=RYjRDmEYOx\" data-secret=\"RYjRDmEYOx\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n<div class=\"yoast-breadcrumbs\"><span><span><a href=\"https:\/\/aroundthe-world.net\/web\/home\/\">Home<\/a><\/span> \u00bb <span class=\"breadcrumb_last\" aria-current=\"page\">FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09\u306e\u5bfe\u7b56\u3068\u6e96\u5099\uff5c\u7a81\u7136\u306e\u67fb\u5bdf\u306b\u3082\u614c\u3066\u306a\u3044\u305f\u3081\u306b<\/span><\/span><\/div>\n\n\n<p class=\"wp-block-paragraph\">\u203b\u672c\u8a18\u4e8b\u306e\u60c5\u5831\u306f\u57f7\u7b46\u65e5\u6642\u70b9\u306e\u3082\u306e\u3067\u3059\u3002\u4eca\u5f8c\u30b5\u30fc\u30d3\u30b9\u5185\u5bb9\u3084\u6599\u91d1\u7b49\u304c\u5909\u66f4\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u306e\u3067\u3001\u6700\u65b0\u60c5\u5831\u306f\u5404\u516c\u5f0f\u30b5\u30a4\u30c8\u3067\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-group is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\"><\/div>\n\n\n\n<div class=\"wp-block-group is-content-justification-center is-nowrap is-layout-flex wp-container-core-group-is-layout-d05cb3ef wp-block-group-is-layout-flex\"><\/div>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">\u3054\u5e0c\u671b\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u9078\u629e\u3044\u305f\u3060\u304f\u3053\u3068\u3067\u3001\u9069\u5207\u306a\u30b5\u30fc\u30d3\u30b9\u30fb\u304a\u554f\u5408\u305b\u30da\u30fc\u30b8\u3078\u3068\u3054\u6848\u5185\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n<\/blockquote>\n\n\n<div id=\"yesno_wrap\">\n<input type=\"hidden\" id=\"sid\" name=\"sid\" value=\"2\" \/>\n<div id=\"question_wrap\">\n<dl class=\"yesno_q q1\" id=\"q26\">\n\t<dt><span>\u3054\u5e0c\u671b\u306e\u30b5\u30fc\u30d3\u30b9\u306b\u3064\u3044\u3066<\/span><\/dt>\n\t<dd>\u3069\u306e\u3088\u3046\u306a\u30b5\u30fc\u30d3\u30b9\u3092\u3054\u5e0c\u671b\u3067\u3059\u304b\u3002<\/dd>\n<\/dl>\n<\/div>\n<ul id=\"choices\">\n<li><button value=\"25\">\u65e5\u672c\u304b\u3089\u6d77\u5916Amazon\u3078\u7d0d\u54c1\u3057\u305f\u3044<\/button>\n<li><button value=\"24\">\u54c1\u7269\u306f\u65e2\u306b\u6d77\u5916\u306b\u3042\u308a\u3001\u305d\u308c\u3092\u65e5\u672c\u3078\u8fd4\u54c1\u30fb\u6d77\u5916\u3067\u518d\u8ca9\u3057\u305f\u3044<\/button>\n<li><button value=\"27\">\u65e5\u672c\u4ee5\u5916\u306e\u56fd\u304b\u3089\u4ed6\u306e\u56fd\u306eAmazon\u3078\u7d0d\u54c1\u3057\u305f\u3044<\/button>\n<li><button value=\"40\">\u65e5\u672c\u304b\u3089\u6d77\u5916eBay\u30fb\u305d\u306e\u4ed6EC\u30b5\u30a4\u30c8\u7b49\u3078\u7d0d\u54c1\u3057\u305f\u3044<\/button>\n<li><button value=\"46\">\u305d\u306e\u4ed6\uff08\u30d3\u30b8\u30cd\u30b9\u30b5\u30dd\u30fc\u30c8\uff09\u306a\u3069\u3092\u5229\u7528\u3057\u305f\u3044<\/button>\n<\/ul>\n\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u30a2\u30e1\u30ea\u30ab\u3078\u98df\u54c1\u3084\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u5316\u7ca7\u54c1\u306a\u3069\u3092\u8f38\u51fa\u3057\u3066\u3044\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u907f\u3051\u3066\u901a\u308c\u306a\u3044\u306e\u304c\u300cFDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09\u300d\u3067\u3059\u3002 \u300c\u3046\u3061\u306b\u3082\u3044\u3064\u6765\u308b\u306e\u3060\u308d\u3046\uff1f\u300d\u300c\u4f55\u3092\u6e96\u5099\u3057\u3066\u304a\u3051\u3070\u3044\u3044\u306e\u304b\u5206\u304b\u3089\u306a\u3044\u2026\u300d \u305d\u3093\u306a\u4e0d\u5b89\u3092\u62b1\u3048\u308b\u62c5\u5f53\u8005\u306f\u5c11\u306a\u304f\u3042\u308a\u307e\u305b\u3093\u3002\u4eca\u56de\u306f\u3001FDA\u67fb\u5bdf\u306e\u57fa\u672c\u3068\u3001\u5b9f\u969b\u306b\u5f79\u7acb\u3064\u5bfe\u7b56\u30fb\u6e96\u5099\u306e\u30dd\u30a4\u30f3\u30c8\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002 ? FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\u3068\u306f\uff1f FDA\uff08Food and Drug Administration\uff1a\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u56fd\u5185\u5916\u306e\u98df\u54c1\u30fb\u533b\u85ac\u54c1\u30fb\u5316\u7ca7\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3092\u76e3\u7763\u3059\u308b\u6a5f\u95a2\u3067\u3059\u3002 FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\u3068\u306f\u3001\u305d\u306eFDA\u304c\u884c\u3046\u88fd\u9020\u65bd\u8a2d\u30fb\u8f38\u51fa\u696d\u8005\u306a\u3069\u3078\u306e\u67fb\u5bdf\u306e\u3053\u3068\u3002\u76ee\u7684\u306f\u3001\u4f01\u696d\u304cFDA\u306e\u898f\u5236\uff08\u4f8b\uff1acGMP = Current Good Manufacturing Practice\uff09\u306b\u9069\u5207\u306b\u5f93\u3063\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002 ? \u67fb\u5bdf\u306e\u5bfe\u8c61\u306b\u306a\u308b\u4f01\u696d FDA\u306e\u67fb\u5bdf\u5bfe\u8c61\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u4e8b\u696d\u8005\u3067\u3059\u3002 \u7279\u306b\u3001\u904e\u53bb\u306b\u9055\u53cd\u6b74\u304c\u3042\u308b\u4f01\u696d\u3084\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u88fd\u54c1\u3092\u6271\u3046\u65bd\u8a2d\u306f\u3001\u512a\u5148\u7684\u306b\u67fb\u5bdf\u5bfe\u8c61\u306b\u306a\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002 ? \u67fb\u5bdf\u306e\u7a2e\u985e FDA\u67fb\u5bdf\u306b\u306f\u5927\u304d\u304f\u5206\u3051\u30663\u3064\u306e\u30bf\u30a4\u30d7\u304c\u3042\u308a\u307e\u3059\u3002 \u67fb\u5bdf\u306e\u7a2e\u985e \u5185\u5bb9 \u4e88\u544a\u306e\u6709\u7121 Routine Inspection\uff08\u5b9a\u671f\u67fb\u5bdf\uff09 \u5b9a\u671f\u7684\u306b\u884c\u308f\u308c\u308b\u901a\u5e38\u67fb\u5bdf \u901a\u5e38\u306f\u4e8b\u524d\u901a\u77e5\u3042\u308a For Cause Inspection\uff08\u539f\u56e0\u8abf\u67fb\u67fb\u5bdf\uff09 \u82e6\u60c5\u3084\u4e8b\u6545\u5831\u544a\u306a\u3069\u3001\u7279\u5b9a\u306e\u554f\u984c\u306b\u5bfe\u3057\u3066\u884c\u308f\u308c\u308b\u67fb\u5bdf \u591a\u304f\u306e\u5834\u5408\u4e88\u544a\u306a\u3057 Follow-up Inspection\uff08\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u67fb\u5bdf\uff09 \u904e\u53bb\u306e\u9055\u53cd\u662f\u6b63\u5f8c\u306e\u78ba\u8a8d \u4e8b\u524d\u901a\u77e5\u3042\u308a\uff0f\u306a\u3057\u4e21\u65b9\u3042\u308a \u3064\u307e\u308a\u3001\u3044\u3064FDA\u304b\u3089\u9023\u7d61\u304c\u6765\u3066\u3082\u614c\u3066\u306a\u3044\u3088\u3046\u306b\u3001\u5e38\u306b\u67fb\u5bdf\u5bfe\u5fdc\u306e\u6e96\u5099\u3092\u6574\u3048\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u306a\u306e\u3067\u3059\u3002 ? \u67fb\u5bdf\u306e\u6d41\u308c FDA\u67fb\u5bdf\u306e\u4e00\u822c\u7684\u306a\u6d41\u308c\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002 \u67fb\u5bdf\u306e\u7d50\u679c\u3001\u554f\u984c\u304c\u306a\u3051\u308c\u3070\u300cNo Action Indicated\uff08NAI\uff09\u300d\u3001\u8efd\u5fae\u306a\u6307\u6458\u304c\u3042\u308c\u3070\u300cVoluntary Action Indicated\uff08VAI\uff09\u300d\u3001\u91cd\u5927\u306a\u9055\u53cd\u304c\u3042\u308b\u5834\u5408\u306f\u300cOfficial Action Indicated\uff08OAI\uff09\u300d\u3068\u5206\u985e\u3055\u308c\u307e\u3059\u3002 \u26a0\ufe0f \u6307\u6458\u3055\u308c\u3084\u3059\u3044\u30dd\u30a4\u30f3\u30c8 FDA\u67fb\u5bdf\u3067\u3088\u304f\u6307\u6458\u3055\u308c\u308b\u306e\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u70b9\u3067\u3059\u3002 \u300c\u66f8\u3044\u3066\u3042\u308b\u3051\u3069\u904b\u7528\u3055\u308c\u3066\u3044\u306a\u3044\u300d\u30b1\u30fc\u30b9\u3082\u975e\u5e38\u306b\u591a\u304f\u3001\u201c\u8a18\u9332\u3068\u5b9f\u614b\u306e\u6574\u5408\u6027\u201d\u304c\u91cd\u8996\u3055\u308c\u307e\u3059\u3002 ? \u67fb\u5bdf\u5bfe\u7b56\u306e5\u3064\u306e\u6e96\u5099\u30dd\u30a4\u30f3\u30c8 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":9788,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[30],"tags":[44,43,37,42,45,31,23],"class_list":["post-9787","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-30","tag-amazon","tag-ebay","tag-37","tag-42","tag-45","tag-ec"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09\u306e\u5bfe\u7b56\u3068\u6e96\u5099\uff5c\u7a81\u7136\u306e\u67fb\u5bdf\u306b\u3082\u614c\u3066\u306a\u3044\u305f\u3081\u306b - \u30a2\u30e9\u30a6\u30f3\u30c9\u30fb\u30b6\u30fb\u30ef\u30fc\u30eb\u30c9\u682a\u5f0f\u4f1a\u793e<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/aroundthe-world.net\/web\/2025\/11\/03\/inspection\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09\u306e\u5bfe\u7b56\u3068\u6e96\u5099\uff5c\u7a81\u7136\u306e\u67fb\u5bdf\u306b\u3082\u614c\u3066\u306a\u3044\u305f\u3081\u306b - \u30a2\u30e9\u30a6\u30f3\u30c9\u30fb\u30b6\u30fb\u30ef\u30fc\u30eb\u30c9\u682a\u5f0f\u4f1a\u793e\" \/>\n<meta property=\"og:description\" content=\"\u30a2\u30e1\u30ea\u30ab\u3078\u98df\u54c1\u3084\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u5316\u7ca7\u54c1\u306a\u3069\u3092\u8f38\u51fa\u3057\u3066\u3044\u308b\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u907f\u3051\u3066\u901a\u308c\u306a\u3044\u306e\u304c\u300cFDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\uff08\u67fb\u5bdf\uff09\u300d\u3067\u3059\u3002 \u300c\u3046\u3061\u306b\u3082\u3044\u3064\u6765\u308b\u306e\u3060\u308d\u3046\uff1f\u300d\u300c\u4f55\u3092\u6e96\u5099\u3057\u3066\u304a\u3051\u3070\u3044\u3044\u306e\u304b\u5206\u304b\u3089\u306a\u3044\u2026\u300d \u305d\u3093\u306a\u4e0d\u5b89\u3092\u62b1\u3048\u308b\u62c5\u5f53\u8005\u306f\u5c11\u306a\u304f\u3042\u308a\u307e\u305b\u3093\u3002\u4eca\u56de\u306f\u3001FDA\u67fb\u5bdf\u306e\u57fa\u672c\u3068\u3001\u5b9f\u969b\u306b\u5f79\u7acb\u3064\u5bfe\u7b56\u30fb\u6e96\u5099\u306e\u30dd\u30a4\u30f3\u30c8\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002 ? FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\u3068\u306f\uff1f FDA\uff08Food and Drug Administration\uff1a\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u56fd\u5185\u5916\u306e\u98df\u54c1\u30fb\u533b\u85ac\u54c1\u30fb\u5316\u7ca7\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3092\u76e3\u7763\u3059\u308b\u6a5f\u95a2\u3067\u3059\u3002 FDA\u30a4\u30f3\u30b9\u30da\u30af\u30b7\u30e7\u30f3\u3068\u306f\u3001\u305d\u306eFDA\u304c\u884c\u3046\u88fd\u9020\u65bd\u8a2d\u30fb\u8f38\u51fa\u696d\u8005\u306a\u3069\u3078\u306e\u67fb\u5bdf\u306e\u3053\u3068\u3002\u76ee\u7684\u306f\u3001\u4f01\u696d\u304cFDA\u306e\u898f\u5236\uff08\u4f8b\uff1acGMP = Current Good Manufacturing Practice\uff09\u306b\u9069\u5207\u306b\u5f93\u3063\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002 ? \u67fb\u5bdf\u306e\u5bfe\u8c61\u306b\u306a\u308b\u4f01\u696d FDA\u306e\u67fb\u5bdf\u5bfe\u8c61\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u4e8b\u696d\u8005\u3067\u3059\u3002 \u7279\u306b\u3001\u904e\u53bb\u306b\u9055\u53cd\u6b74\u304c\u3042\u308b\u4f01\u696d\u3084\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u88fd\u54c1\u3092\u6271\u3046\u65bd\u8a2d\u306f\u3001\u512a\u5148\u7684\u306b\u67fb\u5bdf\u5bfe\u8c61\u306b\u306a\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002 ? \u67fb\u5bdf\u306e\u7a2e\u985e FDA\u67fb\u5bdf\u306b\u306f\u5927\u304d\u304f\u5206\u3051\u30663\u3064\u306e\u30bf\u30a4\u30d7\u304c\u3042\u308a\u307e\u3059\u3002 \u67fb\u5bdf\u306e\u7a2e\u985e \u5185\u5bb9 \u4e88\u544a\u306e\u6709\u7121 Routine Inspection\uff08\u5b9a\u671f\u67fb\u5bdf\uff09 \u5b9a\u671f\u7684\u306b\u884c\u308f\u308c\u308b\u901a\u5e38\u67fb\u5bdf \u901a\u5e38\u306f\u4e8b\u524d\u901a\u77e5\u3042\u308a For Cause Inspection\uff08\u539f\u56e0\u8abf\u67fb\u67fb\u5bdf\uff09 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Indicated\uff08NAI\uff09\u300d\u3001\u8efd\u5fae\u306a\u6307\u6458\u304c\u3042\u308c\u3070\u300cVoluntary Action Indicated\uff08VAI\uff09\u300d\u3001\u91cd\u5927\u306a\u9055\u53cd\u304c\u3042\u308b\u5834\u5408\u306f\u300cOfficial Action Indicated\uff08OAI\uff09\u300d\u3068\u5206\u985e\u3055\u308c\u307e\u3059\u3002 \u26a0\ufe0f \u6307\u6458\u3055\u308c\u3084\u3059\u3044\u30dd\u30a4\u30f3\u30c8 FDA\u67fb\u5bdf\u3067\u3088\u304f\u6307\u6458\u3055\u308c\u308b\u306e\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u70b9\u3067\u3059\u3002 \u300c\u66f8\u3044\u3066\u3042\u308b\u3051\u3069\u904b\u7528\u3055\u308c\u3066\u3044\u306a\u3044\u300d\u30b1\u30fc\u30b9\u3082\u975e\u5e38\u306b\u591a\u304f\u3001\u201c\u8a18\u9332\u3068\u5b9f\u614b\u306e\u6574\u5408\u6027\u201d\u304c\u91cd\u8996\u3055\u308c\u307e\u3059\u3002 ? \u67fb\u5bdf\u5bfe\u7b56\u306e5\u3064\u306e\u6e96\u5099\u30dd\u30a4\u30f3\u30c8 [&hellip;]\" \/>\n<meta property=\"og:url\" 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