{"id":2207,"date":"2022-12-06T21:02:12","date_gmt":"2022-12-06T21:02:12","guid":{"rendered":"https:\/\/groupetransit.com\/?post_type=blog&#038;p=2207"},"modified":"2025-11-05T02:05:04","modified_gmt":"2025-11-05T07:05:04","slug":"la-fda-amplia-la-flexibilidad-del-requisito-de-identificador-unico-de-instalacion-para-el-registro-de-establecimientos-de-alimentos-hasta-diciembre-de-2022","status":"publish","type":"post","link":"https:\/\/groupetransit.com\/es\/fda-extends-flexibility-for-unique-facility-identifier-requirement-for-food-facility-registration-through-december-2022\/","title":{"rendered":"La FDA extiende la flexibilidad del requisito de identificador \u00fanico de instalaciones para el registro de establecimientos de alimentos hasta diciembre de 2022"},"content":{"rendered":"<p>Las instalaciones nacionales y extranjeras que fabrican, procesan, envasan o almacenan alimentos para consumo humano o animal en los Estados Unidos deben registrarse en la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos. Adem\u00e1s, cada dos a\u00f1os, estas mismas instalaciones deben renovar su registro antes del 31 de diciembre. El \u00faltimo per\u00edodo de renovaci\u00f3n de registro bienal finaliz\u00f3 el 31 de diciembre de 2020. Sin embargo, la FDA hab\u00eda otorgado anteriormente a las instalaciones m\u00e1s tiempo para obtener y presentar un identificador \u00fanico de instalaci\u00f3n (UFI) con su presentaci\u00f3n de registro, un requisito que comenz\u00f3 durante el per\u00edodo de renovaci\u00f3n de registro bienal de 2020. Ahora la FDA est\u00e1\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-enforcement-policy-providing-acceptable-unique-facility-identifier-ufi-2020-food\" target=\"_blank\" rel=\"noreferrer noopener\">Ampliando a\u00fan m\u00e1s<\/a>\u00a0el plazo para obtener y\u00a0<strong>Presentar UFI hasta el 31 de diciembre de 2022<\/strong>.<\/p>\n<p>El requisito de incluir un UFI comenz\u00f3 durante el \u00faltimo per\u00edodo de renovaci\u00f3n de registro bianual y se introdujo de acuerdo con la norma de 2016 que implementa las disposiciones de registro de establecimientos de alimentos en la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos. El requisito se aplica tanto a los establecimientos nuevos que se registran por primera vez como a los que presentan una renovaci\u00f3n de registro. La FDA utilizar\u00e1 el UFI para verificar que la direcci\u00f3n espec\u00edfica del establecimiento asociada con el UFI sea la misma direcci\u00f3n asociada con el registro del establecimiento. En este momento, la FDA reconoce el n\u00famero DUNS como un UFI aceptable para el registro de establecimientos de alimentos. El n\u00famero DUNS es asignado y administrado por Dun &amp; Bradstreet (D&amp;B). Los n\u00fameros DUNS se pueden obtener o confirmar visitando el sitio web de D&amp;B en\u00a0<a href=\"https:\/\/www.dnb.com\/duns-number.html\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.dnb.com\/duns-number.html<\/a>Se ha agregado el campo UFI a la Secci\u00f3n 2, Informaci\u00f3n sobre el nombre y la direcci\u00f3n de la instalaci\u00f3n, del Formulario FDA 3537, Registro de instalaciones alimentarias. Despu\u00e9s de escuchar las inquietudes de las partes interesadas sobre la obtenci\u00f3n de un n\u00famero DUNS de manera oportuna, la FDA public\u00f3\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-enforcement-policy-providing-acceptable-unique-facility-identifier-ufi-2020-food\" target=\"_blank\" rel=\"noreferrer noopener\">gu\u00eda<\/a>\u00a0el 1 de diciembre de 2020 con informaci\u00f3n sobre lo que las instalaciones deben hacer si no pudieron obtener un n\u00famero DUNS antes del final del per\u00edodo de renovaci\u00f3n que finaliza el 31 de diciembre. La gu\u00eda explic\u00f3 que la FDA ten\u00eda la intenci\u00f3n de permitir que los registrantes ingresen &quot;PENDIENTE&quot; en el campo UFI de su registro si no anticipaban que podr\u00edan obtener un n\u00famero DUNS a tiempo. La FDA tambi\u00e9n explic\u00f3 que no actualizar el registro con un n\u00famero DUNS v\u00e1lido dentro de los 90 d\u00edas resultar\u00eda en la cancelaci\u00f3n del registro por falta de renovaci\u00f3n de acuerdo con 21 CFR 1.230(b).<\/p>\n<p>La FDA entiende que, para algunas personas, obtener un n\u00famero DUNS ha resultado dif\u00edcil. Ahora, la FDA tiene la intenci\u00f3n de permitir a los registrantes m\u00e1s tiempo (hasta el final del pr\u00f3ximo ciclo de registro, el 31 de diciembre de 2022) para enviar un n\u00famero DUNS como parte del requisito de UFI. Esto ayudar\u00e1 a evitar cancelaciones innecesarias de registros debido a las dificultades que puedan tener los registrantes para obtener un n\u00famero DUNS v\u00e1lido y permitir\u00e1 a la FDA mantener la integridad de su inventario de instalaciones alimentarias. Durante este tiempo, la FDA tiene la intenci\u00f3n de seguir permitiendo a los registrantes ingresar \u201cPENDIENTE\u201d en el campo UFI de su registro si no han obtenido un n\u00famero DUNS. La FDA tampoco tiene la intenci\u00f3n de cancelar ning\u00fan registro de instalaciones con UFI que no se puedan verificar en este momento.<\/p>\n<p><strong>TRANSITO GRUPAL<\/strong>\u00a0Puede completar su renovaci\u00f3n con la FDA de forma gratuita.<br \/>\nSi necesita renovar su Agente FDA, hasta el 31 de diciembre de 2022, le ofrecemos un precio especial de $495 en comparaci\u00f3n con el precio de su agente personalizado de $795.<\/p>","protected":false},"excerpt":{"rendered":"<p>Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with the U.S. Food and Drug Administration. In addition, every two years, these same facilities must renew their registration before December 31st. The latest biennial registration renewal period ended on December [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2211,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"class_list":["post-2207","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022 - Groupe Transit<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022 - Groupe Transit\" \/>\n<meta property=\"og:description\" content=\"Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with the U.S. Food and Drug Administration. 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