{"id":42313,"date":"2026-09-16T10:38:10","date_gmt":"2026-09-16T13:38:10","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=42313"},"modified":"2026-09-16T10:38:10","modified_gmt":"2026-09-16T13:38:10","slug":"anmat-prohibio-todos-los-productos-de-dos-laboratorios-por-graves-irregularidades-sanitarias","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=42313","title":{"rendered":"ANMAT prohibi\u00f3 todos los productos de dos laboratorios por graves irregularidades sanitarias"},"content":{"rendered":"<h2>Alerta regulatoria<\/h2>\n<header class=\"cl-24 header-interior interior-top-1\">Las disposiciones publicadas este mi\u00e9rcoles alcanzan a dos empresas farmac\u00e9uticas y a un dispositivo de alta frecuencia. En uno de los casos, el organismo detect\u00f3 fallas sist\u00e9micas en la fabricaci\u00f3n de medicamentos est\u00e9riles y advirti\u00f3 sobre un \u201criesgo elevado para la salud\u201d.<\/header>\n<header><\/header>\n<header>La <b>ANMAT<\/b> dispuso este mi\u00e9rcoles tres nuevas prohibiciones con alcance nacional que afectan a todos los productos elaborados o comercializados por dos laboratorios y a un equipo utilizado en tratamientos est\u00e9ticos. Las medidas quedaron formalizadas mediante las disposiciones 5870\/2026, 5865\/2026 y 5829\/2026.<\/p>\n<p>&nbsp;<\/p>\n<p>La decisi\u00f3n de mayor alcance sanitario afecta a UGAL Farmac\u00e9utica S.A., cuya planta funciona en Ramos Mej\u00eda, provincia de Buenos Aires. El organismo inhibi\u00f3 preventivamente sus actividades productivas, de control de calidad y comercializaci\u00f3n, y prohibi\u00f3 el uso, distribuci\u00f3n y venta de todos los productos elaborados o comercializados por la firma.<\/p>\n<p>La empresa estaba habilitada para fabricar especialidades medicinales est\u00e9riles, entre ellas soluciones parenterales de peque\u00f1o y gran volumen. Durante una inspecci\u00f3n, la autoridad sanitaria detect\u00f3 deficiencias calificadas como cr\u00edticas y mayores en distintos puntos del proceso productivo.<\/p>\n<p>&nbsp;<\/p>\n<h2><b>Fallas en medicamentos est\u00e9riles<\/b><\/h2>\n<p>&nbsp;<\/p>\n<p>Entre las irregularidades se\u00f1aladas aparecen problemas en las condiciones de las \u00e1reas de producci\u00f3n, el sistema de climatizaci\u00f3n y filtrado, el monitoreo ambiental, el control de calidad, la documentaci\u00f3n, la integridad de los datos y la trazabilidad de los lotes.<\/p>\n<p>&nbsp;<\/p>\n<div class=\"banner banner-parrafo\">\n<div id=\"banner-ad-interior-art-2\" data-zone-id=\"124\"><\/div>\n<\/div>\n<p>La <b>ANMAT<\/b> sostuvo que las deficiencias no constitu\u00edan hechos aislados, sino que evidenciaban fallas sist\u00e9micas dentro del sistema de calidad farmac\u00e9utico. Debido a que se trata de medicamentos est\u00e9riles, consider\u00f3 que los incumplimientos implicaban un \u201criesgo elevado para la salud de la poblaci\u00f3n\u201d.<\/p>\n<p>&nbsp;<\/p>\n<figure class=\"embed\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/elonce-media.elonce.com\/fotos-nuevo\/2023\/06\/26\/o_1687801129.jpg\" alt=\"\" width=\"600\" height=\"400\" \/><\/figure>\n<p>&nbsp;<\/p>\n<p>Adem\u00e1s de impedir la continuidad de las actividades, el organismo dispuso avanzar con un sumario sanitario contra la empresa y contra quien ejerce su direcci\u00f3n t\u00e9cnica.<\/p>\n<p>&nbsp;<\/p>\n<h2><b>Otro laboratorio qued\u00f3 alcanzado por una prohibici\u00f3n total<\/b><\/h2>\n<p>&nbsp;<\/p>\n<p>La segunda medida afecta a Laboratorio Trifarma S.R.L., ubicado en Rosario, Santa Fe. En este caso, se orden\u00f3 inhibir sus actividades productivas, de control de calidad, comercializaci\u00f3n y distribuci\u00f3n, adem\u00e1s de prohibir en todo el territorio nacional todos los productos de la firma.<\/p>\n<p>&nbsp;<\/p>\n<p>La intervenci\u00f3n comenz\u00f3 despu\u00e9s de que el Ministerio de Salud santafesino informara el cierre preventivo del establecimiento por no contar con un director t\u00e9cnico designado. Posteriormente, la autoridad nacional constat\u00f3 que tampoco exist\u00eda un Director T\u00e9cnico Farmac\u00e9utico registrado como responsable.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<figure class=\"embed\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/elonce-media.elonce.com\/fotos\/2025\/10\/07\/e_1759822110_15575.webp\" alt=\"\" width=\"600\" height=\"400\" \/><\/figure>\n<p>La investigaci\u00f3n determin\u00f3 adem\u00e1s que la firma hab\u00eda iniciado tr\u00e1mites de registro para productos como vaselina s\u00f3lida y l\u00edquida, Pasta Lassar, \u00e1cido b\u00f3rico, \u00f3leo calc\u00e1reo, cloruro de magnesio, agua oxigenada, diadermina, bicarbonato de sodio y soluci\u00f3n Lugol, pero los expedientes no hab\u00edan sido completados.<\/p>\n<p>&nbsp;<\/p>\n<h2><b>Tambi\u00e9n prohibieron un equipo utilizado en est\u00e9tica<\/b><\/h2>\n<p>&nbsp;<\/p>\n<p>La tercera disposici\u00f3n de <b>ANMAT<\/b> alcanza a todas las series de los equipos identificados como \u201cAlta frecuencia. TEXEL Modelo AF\u201d. El expediente surgi\u00f3 a partir de una consulta judicial sobre dispositivos secuestrados durante un allanamiento realizado en mayo de 2025.<\/p>\n<p>El organismo comprob\u00f3 que el equipo no figuraba registrado ni autorizado. Por ese motivo, se\u00f1al\u00f3 que no pod\u00eda garantizar su calidad, seguridad, aptitud ni estado de conservaci\u00f3n, lo que implicaba un potencial riesgo para quienes pudieran utilizarlo.<\/p>\n<p>&nbsp;<\/p>\n<p>Con las tres resoluciones publicadas este mi\u00e9rcoles, quedaron fuera de circulaci\u00f3n todos los productos de UGAL Farmac\u00e9utica y Trifarma, junto con los equipos TEXEL Modelo AF. Las prohibiciones permanecer\u00e1n vigentes mientras contin\u00faen las actuaciones administrativas y sanitarias correspondientes. Fuente: El Once<\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/?attachment_id=9280\" rel=\"attachment wp-att-9280\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9280\" src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/agrotecnica.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/agrotecnica.png 720w, https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/agrotecnica-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/a><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>Alerta regulatoria Las disposiciones publicadas este mi\u00e9rcoles alcanzan a dos empresas farmac\u00e9uticas y a un dispositivo de alta frecuencia. En&hellip;<\/p>\n","protected":false},"author":3,"featured_media":42314,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"nogoya_volanta":"","nogoya_breaking":false,"nogoya_exclusive":false,"footnotes":""},"categories":[4,3,17],"tags":[],"class_list":["post-42313","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales","category-noticias","category-sociedad"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ANMAT prohibi\u00f3 todos los productos de dos laboratorios por graves irregularidades sanitarias - Victoria Al D\u00eda<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/victoriaaldia.com\/?p=42313\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANMAT prohibi\u00f3 todos los productos de dos laboratorios por graves irregularidades sanitarias - Victoria Al D\u00eda\" \/>\n<meta property=\"og:description\" content=\"Alerta regulatoria Las disposiciones publicadas este mi\u00e9rcoles alcanzan a dos empresas farmac\u00e9uticas y a un dispositivo de alta frecuencia. 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