{"id":1002,"date":"2025-06-10T15:29:39","date_gmt":"2025-06-10T07:29:39","guid":{"rendered":"https:\/\/www.zenith-vn.com\/?p=1002"},"modified":"2025-06-10T15:53:24","modified_gmt":"2025-06-10T07:53:24","slug":"fda-announces-expansion-of-unannounced-inspections-at-foreign-manufacturing-facilities","status":"publish","type":"post","link":"https:\/\/www.zenith-vn.com\/vi\/fda-thong-bao-mo-rong-cac-cuoc-thanh-tra-khong-bao-truoc-tai-cac-co-so-san-xuat-nuoc-ngoai\/","title":{"rendered":"\u200cFDA th\u00f4ng b\u00e1o m\u1edf r\u1ed9ng c\u00e1c cu\u1ed9c thanh tra kh\u00f4ng b\u00e1o tr\u01b0\u1edbc t\u1ea1i c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t n\u01b0\u1edbc ngo\u00e0i"},"content":{"rendered":"<p>V\u00e0o ng\u00e0y 6 th\u00e1ng 5 n\u0103m 2025, C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u00e3 c\u00f4ng b\u1ed1 k\u1ebf ho\u1ea1ch m\u1edf r\u1ed9ng c\u00e1c cu\u1ed9c thanh tra kh\u00f4ng b\u00e1o tr\u01b0\u1edbc t\u1ea1i c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t n\u01b0\u1edbc ngo\u00e0i s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m, thu\u1ed1c thi\u1ebft y\u1ebfu v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00e1c d\u00e0nh cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 b\u1ec7nh nh\u00e2n Hoa K\u1ef3. S\u00e1ng ki\u1ebfn n\u00e0y nh\u1eb1m m\u1ee5c \u0111\u00edch \u0111\u1ea3m b\u1ea3o c\u00e1c c\u00f4ng ty n\u01b0\u1edbc ngo\u00e0i nh\u1eadn \u0111\u01b0\u1ee3c m\u1ee9c \u0111\u1ed9 gi\u00e1m s\u00e1t v\u00e0 ki\u1ec3m tra theo quy \u0111\u1ecbnh gi\u1ed1ng nh\u01b0 c\u00e1c c\u00f4ng ty trong n\u01b0\u1edbc Hoa K\u1ef3.<\/p>\n\n\n\n<p>Trong m\u1ed9t th\u1eddi gian d\u00e0i, c\u00e1c c\u00f4ng ty n\u01b0\u1edbc ngo\u00e0i \u0111\u01b0\u1ee3c h\u01b0\u1edfng l\u1ee3i t\u1eeb ti\u00eau chu\u1ea9n k\u00e9p\u2014nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o tr\u01b0\u1edbc khi ki\u1ec3m tra c\u01a1 s\u1edf, trong khi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t Hoa K\u1ef3 ph\u1ea3i tu\u00e2n theo c\u00e1c ti\u00eau chu\u1ea9n nghi\u00eam ng\u1eb7t m\u00e0 kh\u00f4ng c\u00f3 c\u1ea3nh b\u00e1o tr\u01b0\u1edbc nh\u01b0 v\u1eady. Th\u1ef1c t\u1ebf n\u00e0y k\u1ebft th\u00fac v\u00e0o h\u00f4m nay, \u0111\u00e1nh d\u1ea5u m\u1ed9t b\u01b0\u1edbc quan tr\u1ecdng trong chi\u1ebfn l\u01b0\u1ee3c r\u1ed9ng h\u01a1n c\u1ee7a FDA nh\u1eb1m b\u00ecnh th\u01b0\u1eddng h\u00f3a c\u00e1c cu\u1ed9c ki\u1ec3m tra c\u1ee7a n\u01b0\u1edbc ngo\u00e0i.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, FDA s\u1ebd \u0111\u00e1nh gi\u00e1 c\u00e1c ch\u00ednh s\u00e1ch v\u00e0 ho\u1ea1t \u0111\u1ed9ng c\u1ee7a m\u00ecnh \u0111\u1ec3 t\u0103ng c\u01b0\u1eddng ch\u01b0\u01a1ng tr\u00ecnh thanh tra n\u01b0\u1edbc ngo\u00e0i, c\u1ee7ng c\u1ed1 vai tr\u00f2 c\u1ee7a m\u00ecnh nh\u01b0 l\u00e0 ti\u00eau chu\u1ea9n v\u00e0ng trong gi\u00e1m s\u00e1t theo quy \u0111\u1ecbnh. Th\u00f4ng qua s\u1ef1 thay \u0111\u1ed5i n\u00e0y, FDA \u0111\u1ea3m b\u1ea3o h\u01a1n n\u1eefa r\u1eb1ng m\u1ecdi s\u1ea3n ph\u1ea9m nh\u1eadp v\u00e0o Hoa K\u1ef3 \u0111\u1ec1u an to\u00e0n, h\u1ee3p ph\u00e1p v\u00e0 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ch\u00ednh h\u00e3ng. C\u00e1c cu\u1ed9c thanh tra kh\u00f4ng b\u00e1o tr\u01b0\u1edbc c\u0169ng s\u1ebd gi\u00fap v\u1ea1ch tr\u1ea7n nh\u1eefng k\u1ebb x\u1ea5u l\u00e0m gi\u1ea3 h\u1ed3 s\u01a1 ho\u1eb7c che gi\u1ea5u h\u00e0nh vi vi ph\u1ea1m, ng\u0103n ch\u1eb7n ch\u00fang g\u00e2y nguy hi\u1ec3m cho t\u00ednh m\u1ea1ng c\u1ee7a ng\u01b0\u1eddi d\u00e2n Hoa K\u1ef3. FDA c\u00f3 th\u1ea9m quy\u1ec1n th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng theo quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi b\u1ea5t k\u1ef3 c\u00f4ng ty n\u00e0o c\u1ed1 g\u1eafng tr\u00ec ho\u00e3n, t\u1eeb ch\u1ed1i, h\u1ea1n ch\u1ebf thanh tra ho\u1eb7c t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p cho c\u00e1c cu\u1ed9c thanh tra thu\u1ed1c ho\u1eb7c thi\u1ebft b\u1ecb kh\u00f4ng b\u00e1o tr\u01b0\u1edbc.<\/p>","protected":false},"excerpt":{"rendered":"<p>V\u00e0o ng\u00e0y 6 th\u00e1ng 5 n\u0103m 2025, C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) \u0111\u00e3 c\u00f4ng b\u1ed1 k\u1ebf ho\u1ea1ch m\u1edf r\u1ed9ng c\u00e1c cu\u1ed9c thanh tra b\u1ea5t ng\u1edd t\u1ea1i c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t n\u01b0\u1edbc ngo\u00e0i s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m, thu\u1ed1c thi\u1ebft y\u1ebfu v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00e1c d\u00e0nh cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 b\u1ec7nh nh\u00e2n Hoa K\u1ef3. S\u00e1ng ki\u1ebfn n\u00e0y nh\u1eb1m \u0111\u1ea3m b\u1ea3o c\u00e1c c\u00f4ng ty n\u01b0\u1edbc ngo\u00e0i nh\u1eadn \u0111\u01b0\u1ee3c m\u1ee9c \u0111\u1ed9 gi\u00e1m s\u00e1t v\u00e0 ki\u1ec3m tra theo quy \u0111\u1ecbnh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi c\u00e1c c\u00f4ng ty trong n\u01b0\u1edbc Hoa K\u1ef3. [\u2026]<\/p>","protected":false},"author":2,"featured_media":985,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-1002","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news"],"_links":{"self":[{"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/posts\/1002","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/comments?post=1002"}],"version-history":[{"count":1,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/posts\/1002\/revisions"}],"predecessor-version":[{"id":1003,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/posts\/1002\/revisions\/1003"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/media\/985"}],"wp:attachment":[{"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/media?parent=1002"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/categories?post=1002"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.zenith-vn.com\/vi\/wp-json\/wp\/v2\/tags?post=1002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}