{"id":55507,"date":"2026-03-20T06:19:45","date_gmt":"2026-03-19T21:19:45","guid":{"rendered":"https:\/\/www.sanctionlab.com\/?p=55507"},"modified":"2026-03-23T10:03:35","modified_gmt":"2026-03-23T01:03:35","slug":"fda-%ed%95%9c%ea%b5%ad-%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-%ea%b8%b0%ec%97%85-%eb%8b%a4%ec%88%98-%ec%a0%81%ec%83%89%eb%aa%a9%eb%a1%9d-%eb%93%b1%ec%9e%ac%ed%95%b4%eb%8b%b9-%ea%b8%b0%ec%97%85","status":"publish","type":"post","link":"https:\/\/www.sanctionlab.com\/?p=55507","title":{"rendered":"FDA, \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uae30\uc5c5 \ub2e4\uc218 \uc801\uc0c9\ubaa9\ub85d \ub4f1\uc7ac\u2026\ud574\ub2f9 \uae30\uc5c5 \uc81c\ud488 \ubb34\uc870\uac74 \ud1b5\uad00 \ubcf4\ub958"},"content":{"rendered":"

|\ud488\uc9c8\uad00\ub9ac\uaddc\uc815 \ubbf8\uc900\uc218\ub85c \uac80\uc0ac \uc5c6\uc774 \ud1b5\uad00 \ubcf4\ub958(DWPE) \uc870\uce58<\/strong><\/h3>\n

\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4 \uc77c\ubd80\ub97c \uc218\uc785\uacbd\ubcf4(Import Alert) \ub300\uc0c1\uc5d0 \ud3ec\ud568\uc2dc\ud0a4\uace0, \ud574\ub2f9 \uae30\uc5c5 \uc81c\ud488\uc5d0 \ub300\ud574 \uac80\uc0ac \uc5c6\uc774 \ud1b5\uad00\uc744 \ubcf4\ub958\ud558\ub294 \uc870\uce58\ub97c \uc801\uc6a9\ud558\uace0 \uc788\uc74c. \uc774\ubc88 \uc870\uce58\ub294 2026\ub144 3\uc6d4 \uae30\uc900 \uc720\uc9c0\ub418\uace0 \uc788\ub294 Import Alert 89-04<\/a>\uc5d0 \ub530\ub978 \uac83\uc73c\ub85c, \ud2b9\uc815 \uc81c\ud488\uc774 \uc544\ub2cc \uc81c\uc870\uc5c5\uccb4\uc758 \ud488\uc9c8\uad00\ub9ac \uccb4\uacc4 \uc804\ubc18\uc5d0 \ub300\ud55c \ubb38\uc81c\ub97c \uadfc\uac70\ub85c \uc774\ub8e8\uc5b4\uc9c4 \uac83\uc784.<\/p>\n

\uc8fc\uc694 \ub300\uc0c1 \uae30\uc5c5…\ud2b9\uc815 \ud488\ubaa9 \uc544\ub2cc \uc804\uccb4 \uc81c\ud488\uc5d0 \uc601\ud5a5<\/strong><\/h4>\n

\uc774\ubc88 \uc218\uc785\uacbd\ubcf4 \ub300\uc0c1\uc5d0\ub294 \uc544\uc8fc\ud31c(Aju Pharm Co., Ltd.), \ubcf4\uc778 \uba54\ub514\uce74(Boin Medica Co., Ltd.), \ub3d9\ubc29\uc758\ub8cc\uae30\uae30(Dong Bang Medical Supplies Corporation), \uacbd\uc6d0 \uba54\ub514\uceec(Kyungwon Medical Co., Ltd.), \ud544\ub85c\uc2dc\uc2a4(Philosys Co. Ltd.), \uc12c\ud14d(Sometech Incorporated), \uc6d0 \uc778\ub354\uc2a4\ud2b8\ub9ac(Won Industry Co. Ltd.) \ub4f1 \ub2e4\uc218\uc758 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uc774 \ud3ec\ud568\ub41c \uac83\uc73c\ub85c \ud655\uc778\ub428.<\/p>\n

\uc774\ub4e4 \uae30\uc5c5\uc774 \uc0dd\uc0b0\ud558\ub294 \ud488\ubaa9\uc740 \uc0dd\ubd84\ud574\uc131 \uc870\uc9c1 \uace0\uc815\uc6a9 \ud328\uc2a4\ub108, \uc77c\ud68c\uc6a9 \uc8fc\uc0ac\uae30 \ubc0f \uc8fc\uc0ac\uce68, \ud608\ub2f9\uce21\uc815\uae30 \ubc0f \uc2dc\ud5d8\uc9c0, \uc815\ud615\uc678\uacfc\uc6a9 \uc784\ud50c\ub780\ud2b8 \ub4f1\uc73c\ub85c \ub2e4\uc591\ud568.<\/p>\n

\uadf8\ub7ec\ub098 \uc218\uc785\uacbd\ubcf4\uc758 \uc801\uc6a9 \ubc29\uc2dd\uc0c1 \ubb38\uc81c\ub294 \ud2b9\uc815 \uc81c\ud488\uc5d0 \ud55c\uc815\ub418\uc9c0 \uc54a\uace0 \ud574\ub2f9 \uae30\uc5c5\uc774 \uc81c\uc870\ud558\ub294 \ubaa8\ub4e0 \uc758\ub8cc\uae30\uae30\uac00 \uaddc\uc81c \ub300\uc0c1\uc774 \ub418\ub294 \uac83\uc774 \ud2b9\uc9d5\uc784. \uc774\ub294 \uac1c\ubcc4 \uc81c\ud488\uc758 \uacb0\ud568 \uc5ec\ubd80\uc640 \uad00\uacc4\uc5c6\uc774 \uc81c\uc870\uc2dc\uc124 \ub2e8\uc704\uc758 \ub9ac\uc2a4\ud06c\uac00 \uc804\uccb4 \uc81c\ud488\uad70\uc73c\ub85c \ud655\uc0b0\ub418\ub294 \uad6c\uc870\uc784\uc744 \uc758\ubbf8\ud568.<\/p>\n

\ud575\uc2ec \uc0ac\uc720: \ud488\uc9c8\uc2dc\uc2a4\ud15c \uaddc\uc815 \ubbf8\uc900\uc218<\/strong><\/h4>\n

FDA\ub294 \uc774\ubc88 \uc870\uce58\uc758 \uadfc\uac70\ub85c \ud574\ub2f9 \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uc758\ub8cc\uae30\uae30 \ud488\uc9c8\uc2dc\uc2a4\ud15c \uaddc\uc815, \uc989 GMP(Current Good Manufacturing Practice)\ub97c \ucda9\uc871\ud558\uc9c0 \ubabb\ud588\ub2e4\ub294 \uc810\uc744 \uba85\uc2dc\ud558\uace0 \uc788\uc74c. GMP\ub294 \uc758\ub8cc\uae30\uae30\ub098 \uc758\uc57d\ud488\uc774 \uc77c\uad00\ub41c \ud488\uc9c8\uacfc \uc548\uc804\uc131\uc744 \uc720\uc9c0\ud558\ub3c4\ub85d \uc81c\uc870\u00b7\uacf5\uc815\u00b7\uc2dc\uc124\u00b7\uae30\ub85d \uad00\ub9ac \uc804\ubc18\uc5d0 \ub300\ud574 \uaddc\uc815\ud55c \ud488\uc9c8\uad00\ub9ac \uae30\uc900\uc784. \uc774\ub7ec\ud55c \uae30\uc900\uc740 \uae00\ub85c\ubc8c \uacf5\ud1b5 \uc6d0\uce59\uc744 \uae30\ubc18\uc73c\ub85c \ud558\ub294\ub370, \ubbf8\uad6d\uc758 \uacbd\uc6b0 FDA\ub97c \ube44\ub86f\ud55c \uac01\uad6d \uaddc\uc81c\ub2f9\uad6d\uc774 \ubc95\uacfc \uaddc\uc815 \ud615\ud0dc\ub85c \uc81c\uc815\u00b7\uc6b4\uc601\ud558\uace0 \uc788\uc74c.<\/p>\n

\uc218\uc785 \uacbd\ubcf4\uc5d0 \ub530\ub974\uba74, FDA\ub294 \ud574\uc678 \uc81c\uc870\uc2dc\uc124\uc5d0 \ub300\ud55c \ud604\uc7a5 \uc2e4\uc0ac \uacb0\uacfc \ud574\ub2f9 \uc5c5\uccb4\uac00 \uc81c\uc870, \ud3ec\uc7a5, \ubcf4\uad00 \ub610\ub294 \uc124\uce58 \uacfc\uc815\uc5d0\uc11c \uc694\uad6c\ub418\ub294 \ud488\uc9c8\uad00\ub9ac \uae30\uc900\uc744 \uc900\uc218\ud558\uc9c0 \uc54a\ub294\ub2e4\uace0 \ud310\ub2e8\ud560 \uacbd\uc6b0, \uc218\uc785\uacbd\ubcf4 \uc870\uce58\ub97c \ubc1c\ub3d9\ud560 \uc218 \uc788\uc74c.\u00a0\uad6c\uccb4\uc801\uc73c\ub85c\ub294 \u25b2\ud488\uc9c8\uad00\ub9ac \uc2dc\uc2a4\ud15c \ubbf8\ud761 \u25b2\uc81c\uc870 \uacf5\uc815 \ud1b5\uc81c \ubd80\uc871 \u25b2\uc2dc\uc124 \ubc0f \uc7a5\ube44 \uad00\ub9ac \ubd80\uc801\uc808 \u25b2\uae30\ub85d \ubc0f \ubb38\uc11c \uad00\ub9ac \ubd88\uc644\uc804 \ub4f1, \uc81c\ud488 \uc548\uc804\uc131\uacfc \uc77c\uad00\ub41c \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud560 \uc218 \uc5c6\ub294 \uc6b4\uc601 \uc0c1\ud0dc\uac00 \ud655\uc778\ub420 \uacbd\uc6b0 \ud574\ub2f9 \uc870\uce58\uac00 \uc801\uc6a9\ub428.<\/p>\n

\ub610\ud55c FDA\ub294 \uc790\uad6d \uc2e4\uc0ac\ubfd0 \uc544\ub2c8\ub77c \uc678\uad6d \uaddc\uc81c\ub2f9\uad6d\uc758 \uac80\uc0ac \uacb0\uacfc\ub098 \uc815\ubd80 \uac04 \ud611\ub825 \uccb4\uacc4\ub97c \ud1b5\ud574 \ud655\ubcf4\ub41c \uc815\ubcf4 \uc5ed\uc2dc \uadfc\uac70\ub85c \ud65c\uc6a9\ud560 \uc218 \uc788\ub2e4\uace0 \ubc1d\ud788\uace0 \uc788\uc74c.<\/p>\n

\uac80\uc0ac \uc5c6\uc774 \uc5b5\ub958 \uc870\uce58\u2026 \uac15\ub825\ud55c \ud1b5\uad00 \uc81c\ud55c<\/strong><\/h4>\n

\uc774\ubc88 \uc218\uc785\uacbd\ubcf4\uc758 \ud575\uc2ec \uc870\uce58\ub294 ‘\ubb3c\ub9ac\uc801 \uac80\uc0ac \uc5c6\uc774 \uc5b5\ub958(DWPE)\u2019\uc784. \uc774\ub294 \ud1b5\uad00 \ub2e8\uacc4\uc5d0\uc11c \uc81c\ud488\uc744 \uc2e4\uc81c\ub85c \uac80\uc0ac\ud558\uc9c0 \uc54a\ub354\ub77c\ub3c4, \uc11c\ub958 \ubc0f \uae30\uc874 \uc815\ubcf4\ub9cc\uc73c\ub85c \uc218\uc785\uc744 \ucc28\ub2e8\ud560 \uc218 \uc788\ub294 \uac15\ub825\ud55c \uaddc\uc81c \uc218\ub2e8\uc784.\u00a0\uc77c\ub2e8 \ud574\ub2f9 \uae30\uc5c5\uc774 \ub9ac\uc2a4\ud2b8\uc5d0 \ub4f1\uc7ac\ub418\uba74 \ubbf8\uad6d\uc73c\ub85c \uc218\ucd9c\ub418\ub294 \uc81c\ud488\uc740 \uc6d0\uce59\uc801\uc73c\ub85c \uc790\ub3d9 \ubcf4\ub958\ub418\uace0, \uae30\uc5c5\uc774 \ubcc4\ub3c4\uc758 \uc785\uc99d \uc790\ub8cc\ub97c \uc81c\ucd9c\ud558\uc9c0 \uc54a\ub294 \ud55c \ud1b5\uad00\uc774 \ud5c8\uc6a9\ub418\uc9c0 \uc54a\uc74c.<\/p>\n

FDA\ub294 \uc774\uc640 \uad00\ub828\ud574 ‘\uc704\ubc18\uc758 \uc678\uad00(appearance of violation)’\uc774 \ud574\uc18c\ub418\uc5c8\ub2e4\ub294 \uc810\uc744 \ucda9\ubd84\ud788 \uc785\uc99d\ud574\uc57c\ub9cc \uc218\uc785\uacbd\ubcf4 \ud574\uc81c\uac00 \uac00\ub2a5\ud558\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc74c. \uc774\ub294 \ub2e8\uc21c\ud55c \uc2dc\uc815\uc870\uce58 \ubcf4\uace0\uac00 \uc544\ub2c8\ub77c, \uc81c\uc870 \uc2dc\uc2a4\ud15c \uc804\ubc18\uc774 \uaddc\uc815\uc5d0 \ubd80\ud569\ud558\ub3c4\ub85d \uac1c\uc120\ub418\uc5c8\uc74c\uc744 \uac1d\uad00\uc801\uc73c\ub85c \uc99d\uba85\ud574\uc57c \ud568\uc744 \uc758\ubbf8\ud568.<\/p>\n

*\uc704\ubc18\uc758 \uc678\uad00: \uc2e4\uc81c \uc704\ubc18\uc774 \ud655\uc815\ub418\uc9c0 \uc54a\uc558\ub354\ub77c\ub3c4, \uc81c\ucd9c\ub41c \uc790\ub8cc\ub098 \uac80\uc0ac \uacb0\uacfc\ub9cc\uc73c\ub85c \ubc95 \uc704\ubc18\uc774 \uc874\uc7ac\ud560 \uac00\ub2a5\uc131\uc774 \uc788\ub2e4\uace0 \ud569\ub9ac\uc801\uc73c\ub85c \ud310\ub2e8\ub418\ub294 \uc0c1\ud0dc\ub97c \uc758\ubbf8.\u00a0\uc989, FDA\uac00 \ucd5c\uc885\uc801\uc73c\ub85c \uc704\ubc18\uc744 \uc785\uc99d\ud558\uc9c0 \uc54a\uc544\ub3c4, \uac89\uc73c\ub85c \ubcf4\uae30\uc5d0\ub3c4 \uaddc\uc815 \uc704\ubc18\uc73c\ub85c \uc758\uc2ec\ub420 \ub9cc\ud55c \uc815\ud669\uc774 \ucda9\ubd84\ud558\uba74 \uaddc\uc81c \uc870\uce58\ub97c \ucde8\ud560 \uc218 \uc788\ub2e4\ub294 \uae30\uc900\uc784.<\/em><\/p>\n

\ud488\ubaa9 \ubb38\uc81c\uac00 \uc544\ub2cc \uc81c\uc870\uc0ac \ud488\uc9c8\uad00\ub9ac \ub9ac\uc2a4\ud06c<\/strong><\/h4>\n

\uc774\ubc88 \uc0ac\ub840\uc758 \uac00\uc7a5 \ud070 \ud2b9\uc9d5\uc740 \uaddc\uc81c\uc758 \ucd08\uc810\uc774 \uac1c\ubcc4 \uc81c\ud488\uc774 \uc544\ub2c8\ub77c \uc81c\uc870\uc0ac\uc758 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc5d0 \ub9de\ucdb0\uc838 \uc788\ub2e4\ub294 \uc810\uc784.\u00a0\uc608\ub97c \ub4e4\uc5b4 \uc77c\ubd80 \uae30\uc5c5\uc758 \uacbd\uc6b0 \uc8fc\uc0ac\uae30\ub098 \ud608\ub2f9\uce21\uc815\uae30\uc640 \uac19\uc740 \ud2b9\uc815 \uc81c\ud488\uad70\uc774 \uba85\uc2dc\ub418\uc5b4 \uc788\uc73c\ub098, \uc2e4\uc81c \uaddc\uc81c \uc801\uc6a9\uc740 \ud574\ub2f9 \ud488\ubaa9\uc5d0 \ud55c\uc815\ub418\uc9c0 \uc54a\uace0 \ub3d9\uc77c \uc81c\uc870\uc2dc\uc124\uc5d0\uc11c \uc0dd\uc0b0\ub418\ub294 \ubaa8\ub4e0 \uc758\ub8cc\uae30\uae30\ub85c \ud655\uc7a5\ub428.\u00a0\uc774\ub294 FDA\uac00 \uc758\ub8cc\uae30\uae30 \uc548\uc804\uc131\uc744 \uac1c\ubcc4 \uc81c\ud488 \ub2e8\uc704\uac00 \uc544\ub2c8\ub77c, \uc81c\uc870\u00b7\ud488\uc9c8\uad00\ub9ac \uccb4\uacc4 \uc804\ubc18\uc758 \uc2e0\ub8b0\uc131\uc5d0 \uae30\ubc18\ud574 \ud3c9\uac00\ud558\uace0 \uc788\uc74c\uc744 \ubcf4\uc5ec\uc8fc\ub294 \uc0ac\ub840\uc784.<\/p>\n

\uc2dc\uc0ac\uc810\u2026 \uc758\ub8cc\uae30\uae30 \uc218\ucd9c\uc758 \ud575\uc2ec\uc740 \ucef4\ud50c\ub77c\uc774\uc5b8\uc2a4 \uccb4\uacc4<\/strong><\/h4>\n

\uc5c5\uacc4\uc5d0\uc11c\ub294 \uc774\ubc88 \uc870\uce58\ub97c \ub450\uace0 \uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uc2dc\uc7a5\uc5d0\uc11c\uc758 \uacbd\uc7c1\ub825\uc774 \ub2e8\uc21c\ud55c \uae30\uc220\ub825\uc774\ub098 \uac00\uaca9\uc774 \uc544\ub2c8\ub77c \uaddc\uc81c \uc900\uc218 \uc5ed\ub7c9, \ud2b9\ud788 \ud488\uc9c8\uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \uc758\ud574 \uc88c\uc6b0\ub418\uace0 \uc788\uc74c\uc744 \ubcf4\uc5ec\uc8fc\ub294 \uc0ac\ub840\ub85c \ud3c9\uac00\ud558\uace0 \uc788\uc74c. \ud2b9\ud788 FDA\uc758 \ud574\uc678 \uc81c\uc870\uc2dc\uc124 \uc810\uac80 \uac15\ud654\uc640 DWPE \uc801\uc6a9 \ud655\ub300 \ud750\ub984\uc744 \uace0\ub824\ud560 \ub54c, \uc81c\uc870\uc2dc\uc124\uc758 \ud488\uc9c8\uad00\ub9ac \uccb4\uacc4 \uad6c\ucd95\uacfc \uc9c0\uc18d\uc801\uc778 \ucef4\ud50c\ub77c\uc774\uc5b8\uc2a4 \uc720\uc9c0\uac00 \ud5a5\ud6c4 \uc218\ucd9c \uc9c0\uc18d\uc131\uc5d0 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce60 \uac83\uc73c\ub85c \ubcf4\uc784.<\/p>\n

\uacb0\uad6d \uc774\ubc88 \uc218\uc785\uacbd\ubcf4\ub294 \ud2b9\uc815 \uae30\uc5c5\uc5d0 \ub300\ud55c \uc81c\uc7ac\ub97c \ub118\uc5b4 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5 \uc804\ubc18\uc5d0 \ub300\ud574 “\uc81c\ud488\uc774 \uc544\ub2c8\ub77c \uc2dc\uc2a4\ud15c\uc774 \ud3c9\uac00 \ub300\uc0c1”\uc774\ub77c\ub294 \uc810\uc744 \ub2e4\uc2dc \ud55c \ubc88 \ud658\uae30\uc2dc\ud0a4\ub294 \uc0ac\ub840\ub85c \ud574\uc11d\ub428.<\/p>\n","protected":false},"excerpt":{"rendered":"

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