{"id":54940,"date":"2022-04-12T14:54:51","date_gmt":"2022-04-12T18:54:51","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/"},"modified":"2022-04-28T11:30:57","modified_gmt":"2022-04-28T15:30:57","slug":"fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/","title":{"rendered":"A FDA Incorporou Novas Empresas Dentro Da Lista De Alertas De Importa\u00e7\u00e3o Devido A Apresenta\u00e7\u00f5es Fraudulentas"},"content":{"rendered":"

A Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) recentemente incorporou novas empresas \u00e0 lista de Alertas de Importa\u00e7\u00e3o 89-08<\/a> para acusa\u00e7\u00f5es de adultera\u00e7\u00e3o de produtos ou produtos com rotulagem incorreta.<\/p>\n

Os produtos adicionados ao alerta de importa\u00e7\u00e3o incluem kits de teste Covid-19, m\u00e1scaras de prote\u00e7\u00e3o individual, dispositivos dermoabras\u00e3o e term\u00f4metros infravermelhos, entre outros.<\/p>\n

A FDA determinou que esses produtos n\u00e3o possuem o registro 510 (k), Aprova\u00e7\u00e3o Pr\u00e9via Necess\u00e1ria para a Comercializa\u00e7\u00e3o (PMA \u2013 Pre Market Approval) ou Isen\u00e7\u00e3o de Dispositivos de Pesquisa (IDE), conforme necess\u00e1rio para a distribui\u00e7\u00e3o comercial.<\/p>\n

\n

Proteja Sua Empresa Com o Servi\u00e7o de Monitoramento de Conformidade da FDA<\/h3>\n

Para obter mais informa\u00e7\u00f5es sobre o servi\u00e7o de monitoramento de conformidade da FDA, contate o Corp por telefone em: +1 (757) 224-0177, ou por e-mail: compliancemonitor@registrarcorp.com, ou agende uma demonstra\u00e7\u00e3o gratuita para ver o software em a\u00e7\u00e3o.<\/p>\n

Agende uma Demonstra\u00e7\u00e3o<\/a><\/p>\n<\/div>\n

Voc\u00ea verificou se o seu fornecedor est\u00e1 inclu\u00eddo dentro de alertas de importa\u00e7\u00e3o? Continue lendo para saber mais sobre como voc\u00ea pode monitorar seus fornecedores.<\/p>\n

Alertas de Importa\u00e7\u00e3o<\/strong><\/p>\n

Quando a FDA coloca uma empresa em uma lista de alerta de importa\u00e7\u00e3o vermelha, todas as remessas dos produtos inclu\u00eddos nesta lista vermelha desse provedor para os Estados Unidos est\u00e3o sujeitas a Deten\u00e7\u00e3o Sem Exame F\u00edsico (DWPE \u2013 Detention Without Physical Examination). As empresas afetadas pelo alerta de importa\u00e7\u00e3o 89-08 est\u00e3o inclu\u00eddas na lista vermelha, que indica que a FDA notou um padr\u00e3o de n\u00e3o conformidade para empresas. Ao implementar o DWPE, a FDA ajuda a impedir que o mercado insira certos produtos n\u00e3o conformes que s\u00e3o enviados para os Estados Unidos.<\/p>\n

Uma das raz\u00f5es pelas quais a FDA implementa alertas de importa\u00e7\u00e3o \u00e9 “devolver a responsabilidade ao importador para garantir que os produtos importados nos Estados Unidos cumpram as leis e regulamentos da FDA”. A regra do Programa de Verifica\u00e7\u00e3o dos Fornecedores Estrangeiros (FSVP) imp\u00f5e aos importadores a responsabilidade de importar apenas com fornecedores que cumpram os padr\u00f5es exigidos pela FDA.<\/p>\n

Se uma empresa tentar importar produtos que est\u00e3o dentro de um alerta de importa\u00e7\u00e3o, a FDA manter\u00e1 o importador para n\u00e3o garantir que seu fornecedor atenda o que era necess\u00e1rio para evitar o alerta.<\/p>\n

Os importadores s\u00e3o respons\u00e1veis por rastrear as a\u00e7\u00f5es necess\u00e1rias da conformidade do FDA com seus fornecedores, mesmo que qualquer deles estejam em uma lista de alerta de importa\u00e7\u00e3o. Se um dos fornecedores n\u00e3o cumprir o que o padr\u00e3o FDA, o importador deve encontrar um fornecedor que possa atender aos requisitos para substituir o produto afetado.<\/p>\n

Verifica\u00e7\u00e3o de Fornecedores<\/strong><\/p>\n

A FDA pode incorporar fornecedores \u00e0 lista de alertas de importa\u00e7\u00e3o sem o conhecimento do importador. Para evitar que o importador fa\u00e7a compras de uma empresa que n\u00e3o atenda aos requisitos para o marketing, ele deve monitorar continuamente seus fornecedores.<\/p>\n

O Servi\u00e7o de Monitoramento de Conformidade do FDA<\/a> da Registrar Corp ajuda a voc\u00ea a automatizar o monitoramento de conformidade a identificar facilmente vulnerabilidades em sua cadeia de fornecedores.<\/p>\n

O servi\u00e7o de monitoramento \u00e9 uma plataforma digital que compara fornecedores di\u00e1rios com seis bancos de dados da FDA.<\/p>\n

Se a FDA tomou medidas contra um de seus fornecedores, voc\u00ea ser\u00e1 notificado automaticamente. Ao contr\u00e1rio de outros m\u00e9todos que o alerta mais tarde no processo, quando ele pode ser tarde demais para evitar que a FDA tome medidas de conformidade contra sua empresa, o servi\u00e7o de monitoramento alerta-o em tempo real, para que voc\u00ea possa mudar rapidamente de fornecedor quando necess\u00e1rio.<\/p>\n

\n

Proteja Sua Empresa Com o Servi\u00e7o de Monitoramento de Conformidade da FDA<\/h3>\n

Para obter mais informa\u00e7\u00f5es sobre o servi\u00e7o de monitoramento de conformidade da FDA, contate o Corp por telefone em: +1 (757) 224-0177, ou por e-mail: compliancemonitor@registrarcorp.com, ou agende uma demonstra\u00e7\u00e3o gratuita para ver o software em a\u00e7\u00e3o.<\/p>\n

Agende uma Demonstra\u00e7\u00e3o<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

A Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) recentemente incorporou novas empresas \u00e0 lista de Alertas de Importa\u00e7\u00e3o 89-08 para acusa\u00e7\u00f5es de adultera\u00e7\u00e3o de produtos ou produtos com rotulagem incorreta. Os produtos adicionados ao alerta de importa\u00e7\u00e3o incluem kits de teste Covid-19, m\u00e1scaras de prote\u00e7\u00e3o individual, dispositivos dermoabras\u00e3o e term\u00f4metros infravermelhos, entre outros.<\/p>\n","protected":false},"author":30,"featured_media":54857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[44],"tags":[],"class_list":{"0":"post-54940","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-uncategorized-pt","8":"entry"},"yoast_head":"\nA FDA Incorporou Novas Empresas Dentro Da Lista De Alertas De Importa\u00e7\u00e3o Devido A Apresenta\u00e7\u00f5es Fraudulentas - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA Incorporou Novas Empresas Dentro Da Lista De Alertas De Importa\u00e7\u00e3o Devido A Apresenta\u00e7\u00f5es Fraudulentas\" \/>\n<meta property=\"og:description\" content=\"A Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) recentemente incorporou novas empresas \u00e0 lista de Alertas de Importa\u00e7\u00e3o 89-08 para acusa\u00e7\u00f5es de adultera\u00e7\u00e3o de produtos ou produtos com rotulagem incorreta. Os produtos adicionados ao alerta de importa\u00e7\u00e3o incluem kits de teste Covid-19, m\u00e1scaras de prote\u00e7\u00e3o individual, dispositivos dermoabras\u00e3o e term\u00f4metros infravermelhos, entre outros.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2022-04-12T18:54:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-04-28T15:30:57+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/04\/aerial-view-cargo-container-ship-ocean-scaled-e1649789590608.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mason Grandusky\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/\"},\"author\":{\"name\":\"Mason Grandusky\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\"},\"headline\":\"A FDA Incorporou Novas Empresas Dentro Da Lista De Alertas De Importa\u00e7\u00e3o Devido A Apresenta\u00e7\u00f5es Fraudulentas\",\"datePublished\":\"2022-04-12T18:54:51+00:00\",\"dateModified\":\"2022-04-28T15:30:57+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/\"},\"wordCount\":699,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/04\/aerial-view-cargo-container-ship-ocean-scaled-e1649789590608.jpg\",\"articleSection\":[\"Uncategorized @pt\"],\"inLanguage\":\"pt\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-adds-firms-to-import-alert-list-due-to-fraudulent-submissions\/\",\"name\":\"A FDA Incorporou Novas Empresas Dentro Da Lista De Alertas De Importa\u00e7\u00e3o Devido A Apresenta\u00e7\u00f5es Fraudulentas - 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