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{"id":7738,"date":"2020-03-18T11:55:16","date_gmt":"2020-03-18T10:55:16","guid":{"rendered":"https:\/\/www.gocaconsulting.com\/?p=7738"},"modified":"2020-03-18T12:01:05","modified_gmt":"2020-03-18T11:01:05","slug":"la-fda-pospone-temporalmente-las-inspecciones-de-instalaciones-en-el-extranjero-debido-a-covid-19","status":"publish","type":"post","link":"https:\/\/www.gocaconsulting.com\/la-fda-pospone-temporalmente-las-inspecciones-de-instalaciones-en-el-extranjero-debido-a-covid-19\/","title":{"rendered":"La FDA pospone temporalmente las inspecciones de instalaciones en el extranjero debido a COVID-19"},"content":{"rendered":"<p>En respuesta al brote de <strong>COVID-19<\/strong>, la <strong>FDA<\/strong> ha pospuesto la mayor\u00eda de las inspecciones de instalaciones en el extranjero hasta abril por el momento.<\/p>\n<p>La <strong>FDA<\/strong> tom\u00f3 esta decisi\u00f3n en base a la alerta de <strong>Nivel 4<\/strong> decretada por el gobierno estadounidense. Dicha alerta proh\u00edbe que los empleados del gobierno viajen al extranjero y restricciones de acceso a visitantes extranjeros por ciertos pa\u00edses. La <strong>FDA<\/strong> conf\u00eda en sus capacidades para mantener la supervisi\u00f3n de los fabricantes internacionales y los productos importados utilizando herramientas y m\u00e9todos alternativos.<\/p>\n<p>Como medida provisional, la <strong>FDA<\/strong> est\u00e1 empleando herramientas adicionales para garantizar la seguridad de los productos importados a los <strong>EE.UU<\/strong>., Incluida la denegaci\u00f3n de entrada de productos inseguros en los <strong>EE. UU<\/strong>., Ex\u00e1menes f\u00edsicos y\/o muestreo de productos en la fronteras, revisi\u00f3n del historial de cumplimiento previo de una empresa, uso de informaci\u00f3n de gobiernos extranjeros como parte del reconocimiento mutuo y acuerdos de confidencialidad y solicitar registros antes o en lugar de inspecciones de drogas en el sitio. La <strong>FDA<\/strong> ya ha aplicado este sistema a los fabricantes de productos regulados por la <strong>FDA<\/strong> en <strong>China<\/strong> al inicio del brote.<\/p>\n<p>Debido a esta situaci\u00f3n din\u00e1mica, la <strong>FDA<\/strong> continuar\u00e1 evaluando y calibrando su enfoque seg\u00fan sea necesario para ayudar a avanzar en respuesta federal en la lucha contra el <strong>COVID-19.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>En respuesta al brote de COVID-19, la FDA ha pospuesto la mayor\u00eda de las inspecciones de instalaciones en el extranjero&#8230;<\/p>\n","protected":false},"author":2,"featured_media":6250,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_oct_exclude_from_cache":false,"footnotes":""},"categories":[50],"tags":[177,8,10,180],"class_list":{"0":"post-7738","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-publicaciones","8":"tag-covid-19","9":"tag-fda","10":"tag-fsma","11":"tag-inspecciones"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.9 - 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