{"id":16136,"date":"2026-04-22T03:16:38","date_gmt":"2026-04-22T06:16:38","guid":{"rendered":"https:\/\/impactocastex.com.ar\/?p=16136"},"modified":"2026-04-22T03:16:38","modified_gmt":"2026-04-22T06:16:38","slug":"la-anmat-suspendio-dos-laboratorios-por-incumplimientos-en-los-certificados-de-buenas-practicas","status":"publish","type":"post","link":"https:\/\/impactocastex.com.ar\/?p=16136","title":{"rendered":"La Anmat suspendi\u00f3 dos laboratorios por incumplimientos en los certificados de Buenas Pr\u00e1cticas"},"content":{"rendered":"<p>La <b>Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (<\/b><a href=\"https:\/\/www.lanacion.com.ar\/sociedad\/la-anmat-suspendio-las-actividades-de-transito-de-un-laboratorio-por-irregularidades-nid21042026\/\" target=\"_blank\" rel=\"noreferrer\" title=\"https:\/\/www.lanacion.com.ar\/sociedad\/la-anmat-suspendio-las-actividades-de-transito-de-un-laboratorio-por-irregularidades-nid21042026\/\"><b>Anmat<\/b><\/a><b>) <\/b>suspendi\u00f3 este martes actividades de dos laboratorios por irregularidades. Seg\u00fan estableci\u00f3 en las disposiciones publicadas en el Bolet\u00edn Oficial, ambos incumplieron las Buenas Pr\u00e1cticas de la entidad ya que uno comercializaba medicamentos vencidos y otro operaba sin un director t\u00e9cnico.<\/p>\n<p>En la Disposici\u00f3n 2063\/2026, el organismo suspendi\u00f3 a la firma <b>Biogamma <\/b>como \u201cempresa importadora de productos m\u00e9dicos\u201d y \u201cdistribuidor de productos m\u00e9dicos y para diagn\u00f3stico de uso \u2018in vitro\u2019 sin cadena de fr\u00edo\u201d, cuyo establecimiento se encuentra en la provincia de Mendoza.<\/p>\n<p>La Anmat explic\u00f3 que, en este caso, el laboratorio solicit\u00f3 la renovaci\u00f3n de su autorizaci\u00f3n como distribuidor para efectuar tr\u00e1nsito interjurisdiccional de productos m\u00e9dicos, sin embargo, en la inspecci\u00f3n se detectaron <b>incumplimientos de la normativa<\/b>. \u201cEn el dep\u00f3sito destinado a productos importados y nacionales aprobados se observaron productos vencidos, sin r\u00f3tulo de importaci\u00f3n, destinados a esterilizaci\u00f3n y almacenamiento de productos de re\u00faso\u201d, marc\u00f3.<\/p>\n\n<p>Adem\u00e1s advirti\u00f3 que respecto a la trazabilidad del producto importado identificado como \u201cXBA Biotan modular femoral steam uncemented 11,25 x 140 mm, fabricado por Biotech GmbH (Alemania), Lote N.\u00ba O00135, con vencimiento 30\/11\/2030 y PM N.\u00ba 1972-26\u2033, la firma no aport\u00f3 la totalidad de la documentaci\u00f3n requerida al momento de la inspecci\u00f3n.<\/p>\n<p>\u201cEl dep\u00f3sito de productos nacionales se encontraba compartiendo con actividades de re\u00faso, cuya pr\u00e1ctica no est\u00e1 permitida, mientras que ambos dep\u00f3sitos presentaban manchas de humedad y deterioro edilicio, evidenciado por techos descascarados\u201d, detall\u00f3 la entidad.<\/p>\n\n<p>En esta l\u00ednea, la Anmat indic\u00f3 que la firma no contaba con toda la documentaci\u00f3n y registros que respalden el cumplimiento de las Buenas Pr\u00e1cticas de fabricaci\u00f3n y realizaba actividades que pueden resultar \u201cda\u00f1inas y peligrosas en cuanto a contaminaci\u00f3n y confusi\u00f3n de los productos m\u00e9dicos\u201d.<\/p>\n<p>Por otra parte, a trav\u00e9s de la Disposici\u00f3n 2144\/2026, la Anmat suspendi\u00f3 el certificado de Buenas Pr\u00e1cticas para la Fabricaci\u00f3n de la empresa <b>Ripezzi <\/b>porque carecer de un director t\u00e9cnico a cargo. La \u00faltima funcionaria en ocupar el puesto lo abandon\u00f3 el 18 de febrero de 2026 y a la firma se le dio un plazo de 10 d\u00edas para reemplazarla, pero no cumpli\u00f3.<\/p>\n<p>En este sentido, tambi\u00e9n se prohibi\u00f3 el uso, comercializaci\u00f3n y distribuci\u00f3n con destino al tr\u00e1nsito interjurisdiccional de todos los productos y lotes importados por la firma, ya que todos ellos fueron adquiridos sin un director t\u00e9cnico a cargo.<\/p>\n<p>\u200bSe trata de Biogamma y Ripezzi, firmas a las que se les establecieron sanciones hasta que se regularicen\u00a0\u00a0<\/p>","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (Anmat) suspendi\u00f3 este martes actividades de&#8230;<\/p>\n","protected":false},"author":1,"featured_media":16137,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[89],"tags":[],"class_list":["post-16136","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>La Anmat suspendi\u00f3 dos laboratorios por incumplimientos en los certificados de Buenas Pr\u00e1cticas -<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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