Waterford<\/a> city during which they found \u201csignificant violations\u201d of manufacturing standards. 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>\nIn a warning letter to Genzyme in late June, the FDA said the plant\u2019s quality control unit \u201cfailed to exercise its responsibility to ensure that drug products are manufactured in compliance with [current good manufacturing practice] and meet established specifications for identity, strength, quality, and purity\u201d as required by FDA regulations.<\/p>\n
The letter states the issues demonstrate a pattern of failure in exercising proper oversight, including in relation to data integrity. The plant failed to keep proper laboratory records and did not thoroughly investigate manufacturing discrepancies or batch failures, it said.<\/p>\n
\u201cFor example, at the time of the inspection, your firm cancelled numerous deviations without investigating the root cause or assessing product impact.\u201d<\/p>\n
The FDA also took issue with Genzyme\u2019s response to the findings from the January report. The firm said it had implemented corrective measures but the FDA said these do not address the \u201cunderlying failure of the quality unit\u201d to ensure compliance with regulations.<\/p>\n
Under US law, Genzyme\u2019s products are considered \u201cadulterated\u201d because the \u201cmethods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to [current good manufacturing practice]\u201d, the FDA said.<\/p>\n
It added that the introduction of Genzyme products into US interstate commerce \u201cis a prohibited act\u201d.<\/p>\n
The FDA said the warning letter is intended to provide the Waterford company an opportunity to address the concerns. It warned that failure to adequately address the issue may result in further action, including seizures or injunctions. <\/p>\n
Sanofi purchased Genzyme in 2011 and since then has invested more than \u20ac700 million in the Waterford facility. In 2024, the Waterford subsidiary, which is one of the biggest employers in the southeast, recorded revenues \u20ac1.65 billion and pretax profits of \u20ac328.5 million.<\/p>\n
In response to queries, a spokesman for Sanofi said it does not a anticipate any impact on medicines supply \u201cat this time\u201d due to the warning.<\/p>\n
\u201cWe 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 the spokesman said.<\/p>\n
\u201cWe will work with the FDA to ensure our action plans fully meet the agency\u2019s requirements and expectations.\u201d<\/p>\n
He said all products from the Waterford plant \u201cmeet established quality and safety specifications\u201d.<\/p>\n
\u201cSanofi is taking the learnings and feedback from the FDA to further strengthen our existing policies, procedures and controls to ensure the continued safety and quality of our products. <\/p>\n
\u201cIn addition, we are onboarding significant additional resources to accelerate implementation of the corrective actions, and our quality team are implementing robust, comprehensive controls to ensure rigorous oversight of all ongoing and future manufacturing operations.\u201d<\/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":529932,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[72,25879,225626,61,60,89558,6513],"class_list":["post-529931","post","type-post","status-publish","format-standard","has-post-thumbnail","category-business","tag-business","tag-food-and-drugs-administration","tag-genzyme","tag-ie","tag-ireland","tag-sanofi","tag-waterford"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/529931","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=529931"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/529931\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/529932"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=529931"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=529931"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=529931"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}