{"id":8640,"date":"2022-04-05T12:16:07","date_gmt":"2022-04-05T16:16:07","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/how-does-an-fda-recall-work\/"},"modified":"2022-04-05T12:16:07","modified_gmt":"2022-04-05T16:16:07","slug":"bir-fda-hatirlama-nasil-calisir","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/tr\/article\/bir-fda-hatirlama-nasil-calisir\/","title":{"rendered":"Bir FDA Geri \u00c7a\u011f\u0131rma Nas\u0131l \u00c7al\u0131\u015f\u0131r?"},"content":{"rendered":"<p>A\u00e7\u0131k\u00e7a s\u00f6ylemek gerekirse, G\u0131da ve \u0130la\u00e7 \u0130daresi asla tehlikeli bir g\u0131da, ila\u00e7, t\u0131bbi cihaz veya ba\u015fka bir \u00fcr\u00fcn\u00fc geri \u00e7a\u011f\u0131rmaz. Teknik olarak, FDA bir geri \u00e7a\u011f\u0131rma \u00f6nerir.<\/p>\n<p>2020 <a href=\"https:\/\/www.congress.gov\/116\/bills\/hr5578\/BILLS-116hr5578ih.pdf\" target=\"_blank\" rel=\"noopener\">G\u00fcvenli Olmayan \u0130la\u00e7lar Yasas\u0131n\u0131 Geri \u00c7a\u011f\u0131r\u0131n<\/a> ajansa bu g\u00fcc\u00fc verecekti. Beklendi\u011fi gibi, ila\u00e7 \u015firketleri ve benzeri di\u011fer \u015firketler tasar\u0131ya derhal kar\u015f\u0131 \u00e7\u0131kt\u0131lar.<\/p>\n<p>Ek olarak, resmi bir geri \u00e7a\u011f\u0131rma, yaralanan kurbanlar\u0131 tazmin etmek i\u00e7in hi\u00e7bir \u015fey yapmaz ve sorumlu \u015firket \u00f6ylece \u00e7ekip gider. Bu kurbanlar\u0131n tazminata ihtiyac\u0131 var ve adaleti hak ediyorlar.<\/p>\n<p>A <a href=\"\/tr\/uygulama-alanlari-2\/kisisel-yaralanma\/\">New York ki\u015fisel yaralanma avukat\u0131<\/a> bu \u015feyleri sa\u011flamaya yard\u0131mc\u0131 olabilir. Mevcut telafi edici zararlar genellikle t\u0131bbi faturalar gibi ekonomik kay\u0131plar ve a\u011fr\u0131 ve \u0131st\u0131rap gibi ekonomik olmayan kay\u0131plar i\u00e7in para i\u00e7erir.<\/p>\n<p>Adalet, ek cezai zararlar \u015feklinde gelir. Bu zararlar pervas\u0131z \u015firketleri en \u00e7ok onlar\u0131 incitti\u011fi yerden vurur.<\/p>\n<h3>\u00dcr\u00fcn G\u00fcvenli\u011fi Sorunlar\u0131<\/h3>\n<p>Yeni \u00fcr\u00fcn geli\u015ftirme veya mevcut \u00fcr\u00fcn \u00fcretimi s\u0131ras\u0131nda, FDA genellikle uygulamal\u0131 bir yakla\u015f\u0131m benimsemez. Bunun yerine, bu ajans genellikle \u00fcreticilerin verdi\u011fi bilgilere g\u00fcvenir.<\/p>\n<p>Sekt\u00f6r kullan\u0131c\u0131 \u00fccretleri hesab\u0131 <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-basics\/fact-sheet-fda-glance\" target=\"_blank\" rel=\"noopener\">neredeyse yar\u0131m<\/a> FDA&#039;n\u0131n b\u00fct\u00e7esinden. Ba\u015fka bir deyi\u015fle, ne kadar \u00e7ok t\u0131bbi, g\u0131da ve di\u011fer \u00fcr\u00fcnler onaylan\u0131rsa, ajans o kadar \u00e7ok para kazan\u0131r.<\/p>\n<p>Bu nedenle, baz\u0131 tehlikeli \u00fcr\u00fcnlerin \u00e7atlaklardan s\u0131zmas\u0131 \u015fa\u015f\u0131rt\u0131c\u0131 de\u011fildir. Bu tehlikeli \u00fcr\u00fcnler genellikle \u015funlar\u0131 i\u00e7erir:<\/p>\n<ul>\n<li><strong>Imalat hatalar\u0131<\/strong>: \u00c7o\u011fu g\u0131da geri \u00e7a\u011f\u0131rma tavsiyesi, \u00fcretim kusurlar\u0131 veya daha spesifik olarak i\u015fleme kusurlar\u0131d\u0131r. Kirli bir kesme b\u0131\u00e7a\u011f\u0131 veya g\u00fcvenli olmayan paketleme gibi, i\u015flem s\u0131ras\u0131nda herhangi bir yerdeki bir kusur, normalde g\u00fcvenli olan bir \u015feyi \u00e7ok g\u00fcvensiz hale getirir.<\/li>\n<li><strong>Tasar\u0131m Kusurlar\u0131<\/strong>: En tehlikeli ila\u00e7 geri \u00e7a\u011f\u0131rmalar\u0131, tasar\u0131m kusurlar\u0131n\u0131 i\u00e7erir. Bu \u015firketler ila\u00e7lar\u0131n\u0131 olabildi\u011fince g\u00fc\u00e7l\u00fc hale getirmeye \u00e7al\u0131\u015f\u0131yor. Sonu\u00e7 olarak, bu ila\u00e7lar genellikle \u00e7ok ciddi yan etkilere sahiptir. <a href=\"\/tr\/uygulama-alanlari-2\/ilac-davasi\/zantac-yaralanma-avukatlari\/\">Zantac<\/a> bu kural\u0131n \u00f6nemli istisnalar\u0131ndan biridir. Zantac&#039;\u0131n NDMA kontaminasyonunun sorumlusu muhtemelen g\u00fcvenli olmayan depolamad\u0131r (\u00fcretim hatas\u0131).<\/li>\n<\/ul>\n<p>Bazen \u015firketler bu sorunlar kar\u015f\u0131s\u0131nda tamamen gafil avlan\u0131r ve \u00e7abucak do\u011fru olan\u0131 yaparlar.<\/p>\n<p>Bununla birlikte, genellikle \u015firketler olumsuz bilgileri olabildi\u011fince uzun s\u00fcre gizler.<\/p>\n<p>Sadece k\u00f6\u015feye s\u0131k\u0131\u015ft\u0131klar\u0131nda ters tepki verirler. New York \u00fcr\u00fcn sorumluluk avukatlar\u0131m\u0131z genellikle bu son durumlarda cezai tazminat alabilir.<\/p>\n<h3>Geri \u00c7a\u011f\u0131rma \u00d6neri S\u00fcreci<\/h3>\n<p>Olumsuz sorunlar\u0131n raporlar\u0131n\u0131 ald\u0131\u011f\u0131 i\u00e7in normalde FDA, geri \u00e7a\u011f\u0131rma \u00f6neri s\u00fcrecini ba\u015flat\u0131r. Bu sorunlar ger\u00e7ek veya potansiyel yaralanmalar olabilir.<\/p>\n<p>Sa\u011fl\u0131k Tehlikesi De\u011ferlendirmesi<\/p>\n<p>Ba\u015flang\u0131\u00e7ta, FDA bir toplant\u0131 ayarlar. Bilim adamlar\u0131ndan olu\u015fan bir ekip, a\u015fa\u011f\u0131daki gibi \u015feyleri belirlemek i\u00e7in bir araya gelir:<\/p>\n<ul>\n<li>Tehlikeli \u00fcr\u00fcne ba\u011fl\u0131 sa\u011fl\u0131k durumlar\u0131,<\/li>\n<li>Neden (<em>G<\/em>. \u00fcr\u00fcn\u00fcn veya ba\u015fka bir \u015feyin sa\u011fl\u0131k ko\u015fullar\u0131na neden olup olmad\u0131\u011f\u0131),<\/li>\n<li>Ya\u015fl\u0131 insanlar, \u00e7ocuklar ve di\u011fer savunmas\u0131z gruplar i\u00e7in tehlikeler,<\/li>\n<li>Tehlikenin ciddiyeti ve<\/li>\n<li>Olas\u0131 uzun vadeli sonu\u00e7lar.<\/li>\n<\/ul>\n<p>Teknik olarak, ila\u00e7 \u015firketi veya di\u011fer \u00fcr\u00fcn \u00fcreticisi, sa\u011fl\u0131k tehlikesi de\u011ferlendirmesi s\u0131ras\u0131nda s\u00f6z sahibi de\u011fildir.<\/p>\n<h3>Geri \u00c7a\u011f\u0131rma S\u0131n\u0131fland\u0131rmas\u0131<\/h3>\n<p>Bu ekip t\u00fcm bunlar\u0131 de\u011ferlendirip bir rapor yay\u0131nlad\u0131ktan sonra, FDA uygun geri \u00e7a\u011f\u0131rma s\u0131n\u0131fland\u0131rmas\u0131na karar verir. Kategoriler:<\/p>\n<ul>\n<li>G\u00fcvenlik Uyar\u0131s\u0131 (genellikle \u00fcr\u00fcn\u00fcn talimatlar\u0131na ve\/veya uyar\u0131lar\u0131na ek olarak),<\/li>\n<li>Piyasadan \u00c7ekilme (ciddi kusurlu olmayan \u00fcr\u00fcnlerin g\u00f6n\u00fcll\u00fc olarak piyasadan \u00e7\u0131kar\u0131lmas\u0131),<\/li>\n<li>S\u0131n\u0131f 3 Geri \u00c7a\u011f\u0131rma (uzak bir ciddi yaralanma olas\u0131l\u0131\u011f\u0131),<\/li>\n<li>S\u0131n\u0131f 2 Geri \u00c7a\u011f\u0131rma (y\u00fcksek ciddi yaralanma olas\u0131l\u0131\u011f\u0131) ve<\/li>\n<li>S\u0131n\u0131f 1 Geri \u00c7a\u011f\u0131rma (makul ciddi veya \u00f6l\u00fcmc\u00fcl yaralanma olas\u0131l\u0131\u011f\u0131).<\/li>\n<\/ul>\n<p>FDA, sa\u011fl\u0131k tehlikesi de\u011ferlendirmesini ve geri \u00e7a\u011f\u0131rma de\u011ferlendirmesini \u00fcreticiye bildirir. Bir sonraki ad\u0131m \u00fcreticiye kalm\u0131\u015f. Teknik olarak, \u00fcretici hi\u00e7bir \u015fey yapamad\u0131.<\/p>\n<p>Ancak geri \u00e7a\u011f\u0131rma s\u0131n\u0131fland\u0131rmas\u0131 halka a\u00e7\u0131k oldu\u011fundan, \u00e7o\u011fu \u00fcretici uygun \u015fekilde yan\u0131t verir. Olumsuz tan\u0131t\u0131m\u0131 en aza indirmek istiyorlar.<\/p>\n<h3>Geri \u00c7a\u011f\u0131rma Stratejisi<\/h3>\n<p>Bu noktada FDA, bir geri \u00e7a\u011f\u0131rma stratejisi geli\u015ftirmek i\u00e7in \u00fcreticiyle birlikte \u00e7al\u0131\u015f\u0131r. Bu strateji genellikle geri \u00e7a\u011f\u0131rma noktas\u0131n\u0131 (toptan, perakende veya t\u00fcketici) ve \u00fcreticilerin bu alanda takip etme gereklili\u011fini i\u00e7erir.<\/p>\n<p>\u0130lgili bir notta, \u00fcreticilerin ayr\u0131ca periyodik geri \u00e7a\u011f\u0131rma durum raporlar\u0131 sunma sorumlulu\u011fu vard\u0131r.<\/p>\n<p>Geri \u00e7a\u011f\u0131rma stratejisi ayn\u0131 zamanda bir kamuya a\u00e7\u0131k b\u0131rakma stratejisini de i\u00e7erir. Sosyal medya \u00e7a\u011f\u0131ndan \u00f6nce, bu ad\u0131m belki de geri \u00e7a\u011f\u0131rma stratejisi s\u00fcrecindeki en \u00f6nemli ad\u0131md\u0131.<\/p>\n<p>Ancak bug\u00fcn, FDA ve \u00fcretici geri \u00e7a\u011f\u0131rma stratejilerinden bahsetti\u011finde, kedi \u00e7oktan \u00e7antadan \u00e7\u0131km\u0131\u015ft\u0131r.<\/p>\n<p>FDA&#039;n\u0131n geri \u00e7a\u011f\u0131rma tavsiye s\u00fcreci ma\u011fdurlar\u0131 etkili bir \u015fekilde korumayabilir. bu <a href=\"\/tr\/bize-ulasin\/\">deneyimli New York ki\u015fisel yaralanma avukatlar\u0131<\/a> at Napoli Shkolnik  provide that protection. Reach out to us now for a free consultation.<\/p>","protected":false},"excerpt":{"rendered":"<p>A\u00e7\u0131k\u00e7a s\u00f6ylemek gerekirse, G\u0131da ve \u0130la\u00e7 \u0130daresi asla tehlikeli bir g\u0131da, ila\u00e7, t\u0131bbi cihaz veya ba\u015fka bir \u00fcr\u00fcn\u00fc geri \u00e7a\u011f\u0131rmaz. Teknik olarak, FDA bir geri \u00e7a\u011f\u0131rma \u00f6nerir. 2020 G\u00fcvenli Olmayan \u0130la\u00e7lar\u0131 Geri \u00c7a\u011f\u0131rma Yasas\u0131\u2026<\/p>","protected":false},"author":3,"featured_media":8641,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[803],"tags":[1030,816,820,964,972,978],"class_list":["post-8640","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-product-litigation","tag-food-safety","tag-defective-products","tag-product-liability","tag-personal-injury","tag-fda-recall","tag-fda-warning"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8640","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/comments?post=8640"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8640\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media\/8641"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media?parent=8640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/categories?post=8640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/tags?post=8640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}