{"id":54261,"date":"2021-12-22T09:57:55","date_gmt":"2021-12-22T14:57:55","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-will-continue-unannounced-inspections-in-2022\/"},"modified":"2022-01-07T16:15:49","modified_gmt":"2022-01-07T21:15:49","slug":"fda-will-continue-unannounced-inspections-in-2022","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/","title":{"rendered":"La FDA Continuar\u00e1 Con Las Inspecciones Sin Aviso Previo en 2022"},"content":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) reanudar\u00e1 un programa piloto que dar\u00e1 lugar a inspecciones <em>\u201cin situ\u201d<\/em> sin aviso previo en India y China. La FDA tiene la intenci\u00f3n de comenzar las inspecciones a principios de 2022.<\/p>\n<p>Elizabeth Miller, de la Oficina de Asuntos Regulatorios (ORA) de la FDA, anunci\u00f3 las pr\u00f3ximas inspecciones durante una conferencia virtual organizada por el Instituto de Derecho de Alimentos y Medicamentos el 9 de diciembre de 2021.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>\u00bfPreguntas Sobre Las Inspecciones de la FDA?<\/h3>\n<p>Registrar Corp puede ayudarle a prepararse para una inspecci\u00f3n de la FDA. Para obtener m\u00e1s informaci\u00f3n, ll\u00e1menos al + 1-757-224-0177, env\u00edenos un correo electr\u00f3nico a info@registrarcorp.com o converse con un Asesor Regulatorio las 24 horas del d\u00eda en regstaging.wpengine.com\/livechat.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/es\/livechat\/\">Chate con Nosotros Ahora<\/a><\/p>\n<\/div>\n<p>Siga leyendo el articulo para conocer el programa piloto de inspecci\u00f3n de la FDA y otros planes de inspecci\u00f3n.<\/p>\n<p><strong>Programa Piloto de Inspecciones de la FDA<\/strong><\/p>\n<p>El 13 de julio de 2020, el Comit\u00e9 de Asignaciones de la C\u00e1mara de Representantes public\u00f3 un informe que, entre otras cosas, abord\u00f3 el crecimiento de las instalaciones de fabricaci\u00f3n de medicamentos supervisadas, indicando que las pr\u00e1cticas de inspecci\u00f3n de la FDA no han seguido el ritmo del crecimiento de la industria global. El informe tambi\u00e9n se\u00f1al\u00f3 la disparidad entre las inspecciones de Estados Unidos y fuera de Estados Unidos.<\/p>\n<p>El Comit\u00e9 hizo referencia al programa piloto de 2014 de la FDA en India, que implement\u00f3 inspecciones sin aviso previo. El informe orden\u00f3 a la FDA que reiniciara el piloto, que hab\u00eda descontinuado en 2015. El Comit\u00e9 tambi\u00e9n orden\u00f3 a la FDA que creara un piloto adicional en China.<\/p>\n<p><strong>Otras Noticias de Inspecci\u00f3n<\/strong><\/p>\n<p>Junto con los programas piloto en India y China, la FDA ha ajustado los procedimientos de inspecci\u00f3n para abordar el retraso de las inspecciones. El retraso de las inspecciones de la FDA ocurri\u00f3 a causa de la pandemia de COVID-19.<\/p>\n<p>Aunque las restricciones de viaje han retrasado las inspecciones priorizadas de ciertos supervisores, la FDA planea reanudar estas inspecciones a partir de febrero del 2022. Las inspecciones priorizadas, generalmente anunciadas, son para productos utilizados para tratar enfermedades o afecciones graves o para productos relacionados con un evento adverso grave o un relacionado a un brote de enfermedades transmitidas por alimentos.<\/p>\n<p>La FDA tambi\u00e9n planea continuar utilizando un enfoque h\u00edbrido para realizar inspecciones. Durante la pandemia, la FDA solicit\u00f3 a las instalaciones que enviaran informes antes de las inspecciones <em>in situ<\/em>. Miller inform\u00f3 a la conferencia que este modelo h\u00edbrido probablemente se convierta en algo com\u00fan.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>\u00bfPreguntas Sobre Las Inspecciones de la FDA?<\/h3>\n<p>Registrar Corp puede ayudarle a prepararse para una inspecci\u00f3n de la FDA. Para obtener m\u00e1s informaci\u00f3n, ll\u00e1menos al + 1-757-224-0177, env\u00edenos un correo electr\u00f3nico a <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a> o converse con un Asesor Regulatorio las 24 horas del d\u00eda en <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/es\/livechat\/\">Chate con Nosotros Ahora<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) reanudar\u00e1 un programa piloto que dar\u00e1 lugar a inspecciones \u201cin situ\u201d sin aviso previo en India y China. La FDA tiene la intenci\u00f3n de comenzar las inspecciones a principios de 2022. Elizabeth Miller, de la Oficina de Asuntos Regulatorios (ORA) de la FDA, anunci\u00f3<\/p>\n","protected":false},"author":30,"featured_media":54229,"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":[60],"tags":[],"class_list":{"0":"post-54261","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-es","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>La FDA Continuar\u00e1 Con Las Inspecciones Sin Aviso Previo en 2022 - 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=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La FDA Continuar\u00e1 Con Las Inspecciones Sin Aviso Previo en 2022\" \/>\n<meta property=\"og:description\" content=\"La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) reanudar\u00e1 un programa piloto que dar\u00e1 lugar a inspecciones \u201cin situ\u201d sin aviso previo en India y China. La FDA tiene la intenci\u00f3n de comenzar las inspecciones a principios de 2022. Elizabeth Miller, de la Oficina de Asuntos Regulatorios (ORA) de la FDA, anunci\u00f3\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2021-12-22T14:57:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-01-07T21:15:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/12\/technologist-industrial-worker-hazardous-suit-handling-aggressive-materials-chemical-industry-scaled-e1640185026108.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1709\" \/>\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=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/\"},\"author\":{\"name\":\"Mason Grandusky\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\"},\"headline\":\"La FDA Continuar\u00e1 Con Las Inspecciones Sin Aviso Previo en 2022\",\"datePublished\":\"2021-12-22T14:57:55+00:00\",\"dateModified\":\"2022-01-07T21:15:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/\"},\"wordCount\":517,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2021\/12\/technologist-industrial-worker-hazardous-suit-handling-aggressive-materials-chemical-industry-scaled-e1640185026108.jpg\",\"articleSection\":[\"Medicamentos\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/es\/fda-will-continue-unannounced-inspections-in-2022\/\",\"name\":\"La FDA Continuar\u00e1 Con Las Inspecciones Sin Aviso Previo en 2022 - 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