{"id":31378,"date":"2025-10-07T09:32:55","date_gmt":"2025-10-07T12:32:55","guid":{"rendered":"https:\/\/nogoyatimes.com\/?p=31378"},"modified":"2025-10-07T09:32:55","modified_gmt":"2025-10-07T12:32:55","slug":"la-anmat-inhabilito-a-un-laboratorio-por-irregularidades-en-su-produccion","status":"publish","type":"post","link":"https:\/\/nogoyatimes.com\/?p=31378","title":{"rendered":"La ANMAT inhabilit\u00f3 a un laboratorio por irregularidades en su producci\u00f3n"},"content":{"rendered":"<header class=\"cl-24 header-interior interior-top-1\">La Administraci\u00f3n Nacional de Medicamentos dispuso la inhabilitaci\u00f3n preventiva de Laboratorios Polybius S.A., tras detectar deficiencias en documentaci\u00f3n, control de calidad y trazabilidad de productos. La medida fue publicada en el Bolet\u00edn Oficial,<\/header>\n<header><\/header>\n<header>La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT) orden\u00f3 la inhabilitaci\u00f3n temporal de las actividades productivas del laboratorio\u00a0<b>Polybius S.A.<\/b>, tras detectar irregularidades durante una inspecci\u00f3n realizada en su planta de Rosario.<\/p>\n<p>&nbsp;<\/p>\n<p>La medida, formalizada mediante la\u00a0<b>Disposici\u00f3n N\u00ba 7355\/25<\/b>, fue publicada este lunes en el Bolet\u00edn Oficial y responde a un procedimiento de control que busca garantizar la seguridad y la calidad de los productos medicinales.<\/p>\n<p>&nbsp;<\/p>\n<p>Seg\u00fan el organismo, la decisi\u00f3n tiene car\u00e1cter\u00a0<b>preventivo<\/b>, ya que se detectaron fallas en los registros y la ausencia de trazabilidad en lotes de medicamentos fabricados por la empresa. Se trata de una acci\u00f3n que busca\u00a0<b>mitigar riesgos sanitarios<\/b>\u00a0y evitar que productos con posibles desv\u00edos de calidad lleguen al consumo p\u00fablico.<\/p>\n<h3>Irregularidades detectadas en la inspecci\u00f3n<\/h3>\n<p>La inspecci\u00f3n se realiz\u00f3 el\u00a0<b>3 de septiembre<\/b>\u00a0por parte de la\u00a0<b>Jefatura de Inspecci\u00f3n de Farmacia de la 2\u00ba Circunscripci\u00f3n del Ministerio de Salud de Santa Fe<\/b>, en el marco de una investigaci\u00f3n que involucraba a\u00a0<b>P.L. Rivero y C\u00eda. S.A.<\/b>, otra firma ya inhabilitada previamente por la ANMAT mediante la Disposici\u00f3n N\u00ba 6199\/25.<\/p>\n<p>&nbsp;<\/p>\n<p>Durante el operativo, los inspectores constataron que Polybius hab\u00eda elaborado dos lotes del producto\u00a0<b>Soluci\u00f3n Isot\u00f3nica de Cloruro de Sodio 500 ml (Certificado N\u00ba 39.014)<\/b>\u00a0\u2014identificados con los n\u00fameros 70413108 y 70416108\u2014 sin la firma del responsable t\u00e9cnico.<\/p>\n<p>&nbsp;<\/p>\n<p>Adem\u00e1s, se observaron\u00a0<b>\u00e1reas con calificaciones vencidas<\/b>, documentaci\u00f3n incompleta y\u00a0<b>procedimientos desactualizados<\/b>, lo que representa un incumplimiento a las\u00a0<b>Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF)<\/b>\u00a0exigidas por la autoridad sanitaria.<\/p>\n<p>&nbsp;<\/p>\n<p>Ante estas inconsistencias, el organismo nacional resolvi\u00f3\u00a0<b>mantener la suspensi\u00f3n preventiva de la planta<\/b>\u00a0hasta que se acrediten las correcciones necesarias y se garantice la integridad del proceso productivo.<\/p>\n<p>&nbsp;<\/p>\n<h3>Un antecedente reciente en el sector<\/h3>\n<p>La medida contra Polybius se suma a la inhabilitaci\u00f3n que el\u00a0<b>Instituto Nacional de Medicamentos (INAME)<\/b>\u00a0aplic\u00f3 en septiembre al laboratorio\u00a0<b>Sant Friburg Q.C.I.<\/b>, tambi\u00e9n por deficiencias cr\u00edticas en su sistema de calidad farmac\u00e9utico y por utilizar\u00a0<b>instalaciones no habilitadas<\/b>.<\/p>\n<p>En aquel caso, los inspectores detectaron incumplimientos en los locales, equipos y procesos, adem\u00e1s de modificaciones estructurales no declaradas ante la autoridad sanitaria.<\/p>\n<p>&nbsp;<\/p>\n<p>El INAME advirti\u00f3 que este tipo de situaciones implica un\u00a0<b>riesgo inaceptable para la calidad y seguridad de los pacientes<\/b>, en el marco de una revisi\u00f3n integral de los procedimientos de control de la industria farmac\u00e9utica.<\/p>\n<p>&nbsp;<\/p>\n<h3>Supervisi\u00f3n sanitaria y control de calidad<\/h3>\n<p>La\u00a0<b>ANMAT<\/b>\u00a0reiter\u00f3 que la aplicaci\u00f3n de sanciones o inhabilitaciones preventivas forma parte de su pol\u00edtica de\u00a0<b>vigilancia continua<\/b>, destinada a preservar la salud p\u00fablica y garantizar que los laboratorios cumplan con los est\u00e1ndares nacionales e internacionales.<\/p>\n<p>&nbsp;<\/p>\n<p>Mientras se mantenga la suspensi\u00f3n,\u00a0<b>Laboratorios Polybius S.A.<\/b> deber\u00e1 abstenerse de producir y distribuir medicamentos hasta obtener la autorizaci\u00f3n correspondiente del organismo, tras una nueva verificaci\u00f3n de cumplimiento. Fuente: El Once<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-2114\" src=\"http:\/\/nogoyatimes.com\/wp-content\/uploads\/2023\/07\/estancia-mendoza.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/nogoyatimes.com\/wp-content\/uploads\/2023\/07\/estancia-mendoza.png 720w, https:\/\/nogoyatimes.com\/wp-content\/uploads\/2023\/07\/estancia-mendoza-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/p>\n<p style=\"text-align: center\"><a href=\"http:\/\/nogoyaradios.com\/\"><strong>Escuch\u00e1 La 100 #Nogoy\u00e1<\/strong><\/a><strong>\u00a0en vivo<\/strong><strong>\u00a0Seguinos en\u00a0<\/strong><a href=\"https:\/\/www.facebook.com\/nogoyaradiosnog\"><strong>Facebook<\/strong><\/a><strong>\u00a0Seguinos en\u00a0<\/strong><a href=\"https:\/\/twitter.com\/NogoyaRadios\"><strong>Twitter<\/strong><\/a><\/p>\n<p style=\"text-align: center\"><strong><em>Nogoy\u00e1 Radios es una Agencia de Medios que cuenta con espacios publicitarios adecuados para la difusi\u00f3n de su Empresa, Profesi\u00f3n y\/o Servicios.<\/em><\/strong><a href=\"https:\/\/web.facebook.com\/hashtag\/nogoy%C3%A1\"><strong><em>#Nogoy\u00e1<\/em><\/strong><\/a><strong><em>\u00a0Radios\u00a0<\/em><\/strong><strong><em>3435-429289 \/ 3435-616203 contacto@nogoyaradios.com<\/em><\/strong><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n Nacional de Medicamentos dispuso la inhabilitaci\u00f3n preventiva de Laboratorios Polybius S.A., tras detectar deficiencias en documentaci\u00f3n, control de calidad y trazabilidad de productos. La medida fue publicada en el Bolet\u00edn Oficial, La Administraci\u00f3n Nacional de Medicamentos, Alimentos y&#8230;<\/p>\n","protected":false},"author":2,"featured_media":31379,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,17],"tags":[],"class_list":["post-31378","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 v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>La ANMAT inhabilit\u00f3 a un laboratorio por irregularidades en su producci\u00f3n - Nogoy\u00e1 Times<\/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:\/\/nogoyatimes.com\/?p=31378\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La ANMAT inhabilit\u00f3 a un laboratorio por irregularidades en su producci\u00f3n - Nogoy\u00e1 Times\" \/>\n<meta property=\"og:description\" content=\"La Administraci\u00f3n Nacional de Medicamentos dispuso la inhabilitaci\u00f3n preventiva de Laboratorios Polybius S.A., tras detectar deficiencias en documentaci\u00f3n, control de calidad y trazabilidad de productos. 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