US drug safety inspectors have warned one of Ireland\u2019s largest pharmaceutical plants that it is failing to meet safety standards and manufacturing \u201cadulterated products\u201d.<\/p>\n
According to The Irish Times, Genzyme\u00a0Ireland Limited in Waterford, the Irish arm of the biopharma giant Sanofi was inspected by officials from the US Food and Drug Administration\u00a0(FDA) earlier this year.<\/p>\n
The plant, which employs over 950 people, is subject to FDA inspections as much of its product is sold in the US.<\/p>\n
The FDA found \u201csignificant violations\u201d of manufacturing standards.<\/p>\n
The issues related specifically to the manufacture of Thymoglobulin, which is used in patients to prevent the rejection of kidney transplants, and Altuviiio, a haemophilia treatment.<\/p>\n
In a statement to WLR News, Sanofi said: \u201cPatient safety and the quality of our products are our highest priorities. We take the FDA Warning Letter issued to the Waterford facility with the utmost seriousness. We are taking immediate actions and are committed to fully addressing each of the Agency\u2019s observations, robustly and sustainably.\u201d<\/p>\n
The statement adds: \u201cWe will work with the FDA to ensure our action plans fully meet the Agency\u2019s requirements and expectations. All products released from the Waterford facility meet established quality and safety specifications. We do not anticipate any impact on our ability to supply medicines at this time.\u201d<\/p>\n
For the latest Waterford News<\/a> and Sport<\/a>, tune into WLR News on the hour and download the WLR App for news on demand.<\/p>\n","protected":false},"excerpt":{"rendered":"US drug safety inspectors have warned one of Ireland\u2019s largest pharmaceutical plants that it is failing to meet…\n","protected":false},"author":2,"featured_media":531327,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[72,61,60],"class_list":["post-531326","post","type-post","status-publish","format-standard","has-post-thumbnail","category-business","tag-business","tag-ie","tag-ireland"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/531326","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=531326"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/531326\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/531327"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=531326"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=531326"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=531326"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}