{"id":1487,"date":"2026-04-09T13:42:48","date_gmt":"2026-04-09T04:42:48","guid":{"rendered":"https:\/\/ce-certi.or.kr\/?page_id=1487"},"modified":"2026-04-09T15:23:01","modified_gmt":"2026-04-09T06:23:01","slug":"fda%ec%8b%9d%ed%92%88%eb%93%b1%eb%a1%9d-fsvp","status":"publish","type":"page","link":"https:\/\/ce-certi.or.kr\/?page_id=1487","title":{"rendered":"FDA\uc2dd\ud488\ub4f1\ub85d (FSVP)"},"content":{"rendered":"\t\t
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FDA \uc2dd\ud488 (FSVP)<\/b><\/p>

FSVP \uac1c\uc694<\/h2>

FSVP(Foreign Supplier Verification Program)\ub294 \ubbf8\uad6d FDA\uac00 FSMA(\uc2dd\ud488\uc548\uc804\ud604\ub300\ud654\ubc95)\uc758 \uc77c\ud658\uc73c\ub85c \ub3c4\uc785\ud55c \uc81c\ub3c4\ub85c,
\ud574\uc678 \uacf5\uae09\uc5c5\uccb4\uac00 \ubbf8\uad6d\uc758 \uc2dd\ud488\uc548\uc804 \uae30\uc900\uacfc \ub3d9\ub4f1\ud55c \uc218\uc900\uc758 \uacf5\uc911\ubcf4\uac74 \ubcf4\ud638 \uae30\uc900\uc744 \ucda9\uc871\ud558\uba70 \uc2dd\ud488\uc744 \uc0dd\uc0b0\ud558\ub294\uc9c0 \uac80\uc99d\ud558\uace0,
\uc218\uc785 \uc2dd\ud488\uc774 \ubd88\ub7c9(adulterated)\ud558\uac70\ub098 \uc54c\ub808\ub974\uac90 \ud45c\uc2dc\uc640 \uad00\ub828\ud558\uc5ec \uc624\ud45c\uc2dc(misbranded)\ub418\uc9c0 \uc54a\uc558\uc74c\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574\u00a0
\uc218\uc785\uc790 \ubc0f \ud604\uc9c0\ub300\ub9ac\uc778\uc774 \uc218\ub9bd\ud558\uace0 \ucc45\uc784\uc9c0\uace0 \uac80\uc99d\ud558\ub294 \uccb4\uacc4 \uc785\ub2c8\ub2e4.<\/p>

\uc27d\uac8c \ub9d0\ud558\uba74, \ubbf8\uad6d\uc73c\ub85c \uc2dd\ud488\uc744 \uc218\uc785\ud558\ub294 \ubbf8\uad6d \uce21 \uc218\uc785\uc790 \ubc0f \ud604\uc9c0 \ub300\ub9ac\uc778\uc774, \ud574\uc678 \uacf5\uae09\uc5c5\uccb4(\ud55c\uad6d \uc81c\uc870\uc0ac \ub4f1)\uac00 \ubbf8\uad6d \uc2dd\ud488\uc548\uc804 \uae30\uc900\uc744 \uc81c\ub300\ub85c\u00a0
\uc9c0\ud0a4\uace0 \uc788\ub294\uc9c0 \uc9c1\uc811 \uac80\uc99d\ud558\uace0 \ucc45\uc784\uc838\uc57c \ud55c\ub2e4\ub294 \uaddc\uc815 \uc785\ub2c8\ub2e4.<\/p>

\"\"<\/p>

\u00a0<\/h2>

FSVP \uc758\ubb34\uc790<\/h2>

1. \ud604\uc9c0\ub300\ub9ac\uc778(FSVP Agent) \ubc0f \uc218\uc785\uc790
<\/span><\/i><\/span>\ubbf8\uad6d FDA\uc758 \ud574\uc678\uacf5\uae09\uc790 \uac80\uc99d \ud504\ub85c\uadf8\ub7a8(FSVP) \uaddc\uc815\uc5d0 \ub530\ub77c, \ubbf8\uad6d\uc73c\ub85c \uc2dd\ud488\uc744 \uc218\ucd9c\ud560 \ub54c\ub294 \ubbf8\uad6d \ub0b4 \uc218\uc785\uc790 \ub610\ub294 \uc9c0\uc815\ub41c \ud604\uc9c0\ub300\ub9ac\uc778(FDA Agent)\uc774
\ud574\ub2f9 \uc81c\ud488\uc758 \uc548\uc804\uc131\uc744 \uac80\uc99d\ud558\uace0 \ubc95\uc801 \ucc45\uc784\uc744 \uc774\ud589\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/h2>
    • \uc8fc\uc694 \uc5c5\ubb34 : \uc2dd\ud488 \uc548\uc804 \uaddc\uc815 \uc900\uc218 \uc5ec\ubd80 \uac80\uc99d \ubc0f \uad00\ub828 \uc11c\ub958 \ubcf4\uad00 \ub4f1 FDA\uc2e4\uc0ac \ub300\uc751\uc744 \uc218\ud589 \ud569\ub2c8\ub2e4.<\/li>
    • \ud544\uc218 \uc694\uac74 : \uc774\ud589 \uc8fc\uccb4\ub294 \ubbf8\uad6d \ub0b4 \uc2e4\uc81c \uc8fc\uc18c\uc640 DUNS\ubc88\ud638\ub97c \ubcf4\uc720 \ud574\uc57c \ud558\uba70, \ud1b5\uad00 \uc2dc \ud574\ub2f9 \uc815\ubcf4(FSVP Impoter)\ub85c \uae30\uc7ac\ub429\ub2c8\ub2e4.<\/li><\/ul><\/li><\/ul>

      2. \ud55c\uad6d \uc81c\uc870\uc0ac vs \ud604\uc9c0 \ub300\ub9ac\uc778 \ubc0f \uc218\uc785\uc790 – \uc5ed\ud560 \ube44\uad50
      \"\"<\/span><\/i><\/span><\/h2>
        • \ud604\uc9c0 \ub300\ub9ac\uc778 : \ubbf8\uad6d \ub0b4\uc5d0\uc11c FSVP\uc758 \ubc95\uc801 \ucc45\uc784\uc744 \uc9c0\ub294 \uc8fc\uccb4\ub85c, \ubbf8\uad6d \ub0b4 \uc2e4\uc81c \uc8fc\uc18c\uc640 DUNS \ubc88\ud638\ub97c \ubcf4\uc720\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>
        • \uc801\uaca9 \uac1c\uc778(QI) : \uc704\ud574\uc694\uc18c \ubd84\uc11d, \uacf5\uae09\uc5c5\uccb4 \ud3c9\uac00 \ub4f1 FSVP \uc2e4\ubb34\ub97c \uc9c1\uc811 \uc218\ud589\ud558\ub294 \uc804\ubb38\uac00<\/li><\/ul><\/li><\/ul>

          \u00a0 \u00a0 \u00a0 \u00a0\u203b \ubbf8\uad6d\uc73c\ub85c \uc2dd\ud488\uc744 \uc218\ucd9c\ud558\uae30 \uc704\ud574\uc11c\ub294 \ub450 \uac00\uc9c0 \uc5ed\ud560(\ub300\ub9ac\uc778\/\uc801\uaca9 \uac1c\uc778)\uc774 \ubaa8\ub450 \uac16\ucdb0\uc838\uc57c \ud569\ub2c8\ub2e4.<\/p>

          3. \uc801\uaca9 \uac1c\uc778 (QI) \uc774\ub780?
          <\/span><\/i><\/span>FSVP\uc758 \uac1c\ubc1c \ubc0f \uac80\uc99d \ud65c\ub3d9 \uc804\ubc18\uc740 \ubc18\ub4dc\uc2dc \uc801\uaca9 \uac1c\uc778(Qualified Individual, QI)\uc774 \uc218\ud589\ud574\uc57c \ud569\ub2c8\ub2e4.<\/span><\/h2>
            • \uc2dd\ud488\uc548\uc804 \uad00\ub828 \uad50\uc721 \u00b7 \uacbd\ud5d8\uc744 \uac16\ucd98 \uc790\uc5ec\uc57c \ud569\ub2c8\ub2e4.<\/li>
            • QI\uac00 \uc9c0\uc815\ub418\uc9c0 \uc54a\uc740 FSVP\ub294 \ubc95\uc801 \ud6a8\ub825\uc774 \uc5c6\uc2b5\ub2c8\ub2e4.<\/li><\/ul><\/li><\/ul>

              QI\uac00 \uc218\ud589\ud558\ub294 \uc5c5\ubb34<\/span><\/h2>
                • FSVP \ubb38\uc11c \uac1c\ubc1c : FSVP \uc804\uccb4 \ubb38\uc11c\ub97c \uc791\uc131\ud558\uace0 \uc218\ub9bd<\/li>
                • \uc704\ud574\uc694\uc18c \ubd84\uc11d : \uc218\uc785 \uc2dd\ud488\ubcc4 \uc0dd\ubb3c\ud559\uc801 \u00b7 \ud654\ud559\uc801 \u00b7 \ubb3c\ub9ac\uc801 \uc704\ud574\uc694\uc18c \uc2dd\ubcc4 \ubc0f \ud3c9\uac00<\/li>
                • \uacf5\uae09\uc5c5\uccb4 \ud3c9\uac00 : \uacf5\uae09\uc5c5\uccb4\uc758 FDA \uaddc\uc815 \uc900\uc218 \uc774\ub825, \uc2dd\ud488\uc548\uc804 \uad00\ud589, \uacbd\uace0\uc7a5 \u00b7 Import Alert \uc774\ub825 \uac80\ud1a0<\/li>
                • \uacf5\uae09\uc5c5\uccb4 \uc2b9\uc778 : \ud3c9\uac00 \uacb0\uacfc\ub97c \ubc14\ud0d5\uc73c\ub85c \uacf5\uae09\uc5c5\uccb4 \uc2b9\uc778 \uc5ec\ubd80 \uacb0\uc815<\/li>
                • \uac80\uc99d \ud65c\ub3d9 \uacb0\uc815 \ubc0f \uc218\ud589 : \ud604\uc7a5 \uac10\uc0ac, \uc0d8\ud50c\ub9c1 \u00b7 \uc2dc\ud5d8, \uae30\ub85d \uac80\ud1a0 \ub4f1 \uc801\uc808\ud55c \uac80\uc99d \ubc29\ubc95 \uacb0\uc815 \ubc0f \uc2e4\ud589<\/li>
                • \uac80\uc99d \uacb0\uacfc \uac80\ud1a0 : \uac80\uc99d \ud65c\ub3d9 \uacb0\uacfc\ub97c \ubd84\uc11d\ud558\uace0 \ubb38\uc81c \ubc1c\uc0dd \uc2dc \uc2dc\uc815 \uc870\uce58 \uad8c\uace0<\/li>
                • \uc815\uae30 \uc7ac\ud3c9\uac00 : \ucd5c\uc18c 3\ub144\ub9c8\ub2e4 \ub610\ub294 \uc0c8\ub85c\uc6b4 \uc2dd\ud488\uc548\uc804 \uc815\ubcf4 \ubc1c\uc0dd \uc2dc \uacf5\uae09\uc5c5\uccb4 \uc7ac\ud3c9\uac00<\/li>
                • \uae30\ub85d \uc720\uc9c0 : \ubaa8\ub4e0 FSVP \ud65c\ub3d9 \uad00\ub828 \ubb38\uc11c\ud654 \ubcf4\uad00<\/li><\/ul><\/li><\/ul>

                  \u00a0<\/h2>

                  FSVP \uc801\uc6a9 \ubc0f \uc6b4\uc601 \uc694\uac74<\/h2>

                  1. \uc5b4\ub5a4 \uc2dd\ud488\uc5d0 \uc801\uc6a9\uc774 \ub418\ub098\uc694?
                  <\/span><\/i><\/span>FSVP \uaddc\uc815\uc740 \ubbf8\uad6d\uc73c\ub85c \uc218\uc785\ub418\uac70\ub098 \uc218\uc785\uc774 \uc81c\uc548\ub41c \ubaa8\ub4e0 \uc2dd\ud488\uc5d0 \uc801\uc6a9\ub418\uba70, \uba74\uc81c \ub300\uc0c1\uc774 \uc544\ub2cc \ud55c \uc608\uc678\uac00 \uc5c6\uc2b5\ub2c8\ub2e4.
                  <\/span>
                  \u203b \uc801\uc6a9 \uba74\uc81c \ub300\uc0c1
                  <\/span>\uc8fc\uc2a4 \uc81c\ud488 \ubc0f \uc8fc\uc2a4 \uc81c\uc870\uc6a9 \uc6d0\uc7ac\ub8cc, \uc5b4\ub958 \u00b7 \uc218\uc0b0\ubb3c \uc81c\ud488 \ubc0f \uc218\uc0b0\ubb3c \uac00\uacf5\uc6a9 \uc6d0\uc7ac\ub8cc
                  – \ud574\ub2f9 \uc2dd\ud488\uc5d0 \uc801\uc6a9\ub418\ub294 HACCP \uae30\ubc18 \uaddc\uc815(21 CFR parts 120, 123)\uc744 \uc900\uc218\ud558\ub294 \uacbd\uc6b0 FSVP \uc758\ubb34\uc5d0\uc11c \uba74\uc81c\ub429\ub2c8\ub2e4.
                  \uc774 \uacbd\uc6b0\uc5d0\ub294 \uac01 HACCP \uaddc\uc815\uc5d0 \ub530\ub978 \ubcc4\ub3c4\uc758 \uc218\uc785\uc790\ubc0f \ud604\uc9c0 \ub300\ub9ac\uc778\uc774 \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.
                  – \uadf8 \uc678 \uba74\uc81c \ud56d\ubaa9\uc73c\ub85c\ub294 \ubbf8\uad6d \ub0b4 \ubc18\uc1a1 \uc2dd\ud488, \uac1c\uc778 \uc18c\ube44\uc6a9 \uc2dd\ud488 \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/span><\/h2><\/div><\/div>

                  2. \uc81c\uc870\uc0ac fsvp \ub300\uc751 \uc694\uac74<\/span><\/i><\/h2>

                  \ud574\uc678 \uc81c\uc870\uc5c5\uccb4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c FSVP(\ud574\uc678\uacf5\uae09\uc790\uac80\uc99d\ud504\ub85c\uadf8\ub7a8)\uc758 \ubc95\uc801 \uc758\ubb34 \uc8fc\uccb4\ub294 \uc544\ub2c8\uba70, \ud574\ub2f9 \uc758\ubb34\ub294 \ubbf8\uad6d \ud604\uc9c0 \ub300\ub9ac\uc778 \ubc0f \uc218\uc785\uc790\uc5d0\uac8c \uc788\uc2b5\ub2c8\ub2e4.
                  \uadf8\ub7ec\ub098 <\/span>\uc2e4\uc81c \uac70\ub798 \uacfc\uc815\uc5d0\uc11c\ub294 \ud604\uc9c0 \ub300\ub9ac\uc778 \ubc0f \uc218\uc785\uc790\uac00 FSVP \uc694\uac74\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574 \ud574\uc678 \uc81c\uc870\uc5c5\uccb4\uc5d0 \ub2e4\uc591\ud55c \uc790\ub8cc \uc81c\uacf5\uc744 \uc694\uad6c\ud558\uac8c \ub429\ub2c8\ub2e4.<\/span><\/h2>

                  \uc774\uc5d0 \ub530\ub77c \ud574\uc678 \uc2dd\ud488\ud68c\uc0ac\ub294 \uc544\ub798\uc640 \uac19\uc740 \uc2dd\ud488\uc548\uc804 \uad00\ub828 \uc790\ub8cc\ub97c \uc0ac\uc804\uc5d0 \uc900\ube44\ud560 \ud544\uc694\uac00 \uc788\uc2b5\ub2c8\ub2e4.<\/p>

                  \"\"<\/p>

                  \uc774\ub7ec\ud55c \uc790\ub8cc\ub294 \ubbf8\uad6d \uc218\uc785\uc790 \ubc0f \ud604\uc9c0\ub300\ub9ac\uc778\uc774 \uc218\ud589\ud574\uc57c \ud558\ub294 \uacf5\uae09\uc5c5\uccb4 \ud3c9\uac00 \ubc0f \uc2dd\ud488 \uc704\ud574\uc694\uc18c \ubd84\uc11d\uc744 \ud544\uc218\uc801\uc73c\ub85c \ud65c\uc6a9 \ub429\ub2c8\ub2e4.
                  \ub530\ub77c\uc11c \ud574\uc678 \uc81c\uc870\uc5c5\uccb4\uac00 FSVP \uad00\ub828 \ub300\uc751 \uc790\ub8cc\ub97c \uc0ac\uc804\uc5d0 \uccb4\uacc4\uc801\uc73c\ub85c \uc900\ube44\ud560 \uacbd\uc6b0,
                  \ubbf8\uad6d \uc218\uc785\uc790\uc758 FSVP \uc774\ud589\uc744 \uc9c0\uc6d0\ud560 \uc218 \uc788\uc73c\uba70 \uac70\ub798 \uc2e0\ub8b0\ub3c4 \ud655\ubcf4 \ubc0f \uc218\ucd9c \uacbd\uc7c1\ub825 \uac15\ud654\uc5d0\ub3c4 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/p>

                  3. \ud1b5\uad00 \uc2dc \uc2e0\uc6d0 \ud655\uc778 \uc694\uac74
                  <\/span><\/i><\/span>21 CFR 1.509\uc5d0 \ub530\ub77c,\u00a0 \ubaa8\ub4e0 FSVP \ud604\uc9c0 \ub300\ub9ac\uc778 \ubc0f \uc218\uc785\uc790\ub294\u00a0 \ud1b5\uad00 \uc2e0\uace0 \uc2dc \uc774\ub984, \uc774\uba54\uc77c \uc8fc\uc18c, FDA\uac00 \uc778\uc815\ud55c \uace0\uc720 \uc2dc\uc124\uc2dd\ubcc4\ubc88\ud638(UFI)\ub97c\u00a0
                  \uc81c\ucd9c\ud574\uc57c \ud558\uba70, \ud604\uc7ac FDA\uac00 \uc778\uc815\ud558\ub294 UFI\ub294 DUNS\ubc88\ud638 \uc785\ub2c8\ub2e4.\u00a0<\/span><\/h2>

                  4. \uae30\ub85d \uc720\uc9c0 \uc694\uac74
                  <\/span><\/i><\/span>\ubaa8\ub4e0 FSVP \uad00\ub828 \uae30\ub85d\uc740 \uc11c\uba74\uc73c\ub85c \uad00\ub9ac\ub418\uc5b4\uc57c \ud558\uba70, \uc8fc\uc694 \uc6d0\uce59\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4<\/span>
                  <\/span><\/i><\/span><\/h2><\/div>
                    • \uc678\ubd80 \ubcf4\uad00\ub3c4 \ud5c8\uc6a9\ud558\ub098, \uacf5\uc2dd \uac80\ud1a0 \uc694\uccad \uc2dc 24\uc2dc\uac04 \uc774\ub0b4\uc5d0 \ud604\uc7a5\uc5d0 \uc5f4\ub78c \uac00\ub2a5\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>
                    • \uc804\uc790 \uae30\ub85d\uc740 \ud604\uc7a5\uc5d0\uc11c \uc811\uadfc \uac00\ub2a5\ud55c \uacbd\uc6b0 \ud604\uc7a5 \ubcf4\uad00\uc73c\ub85c \uac04\uc8fc\ub429\ub2c8\ub2e4.<\/li><\/ul><\/li><\/ul>

                      \u00a0<\/h2>

                      FSVP \uc9c4\ud589\uc808\ucc28<\/h2>

                      \"\"<\/p>

                      \"\"<\/p>

                      \u00a0<\/p><\/div><\/div>

                      \u00a0<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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                      \n\t\t\t\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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                      \ube60\ub978 \ubb38\uc758 \ud558\uae30<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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                      \n

                      <\/p>

                        <\/ul><\/div>\n
                        \n
                        \n<\/fieldset>\n