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赛诺菲（Sanofi）旗下 Genzyme 位于爱尔兰沃特福德的工厂，近日收到了美国 FDA 的警告信（Warning Letter）。FDA 检查人员在今年年初的现场检查中发现了 "重大" 生产违规问题，涉及抗排异药物 Thymoglobulin 以及与 Sobi 合作的 A 型血友病药物 Altuviiio。 一、从 Form 483 到警告信：监管升级 这并非该工厂首次被 FDA 点名。早在 2026 年初，FDA 检查人员就曾在现场检查后向 Genzyme 爱尔兰工厂发出过 Form 483（现场检查报告）。而此次警告信的下达，意味着监管力度的进一步升级。 根据 FDA 的记录，检查人员于 2026 年 1 月 12 日至 1 月 20 日对赛诺菲位于爱尔兰沃特福德的工厂进行了现场检查。检查中发现了与两款产品相关的重大生产违规问题： Thymoglobulin（抗胸腺细胞球蛋白 [兔]）：用于预防和治疗肾移植患者的急性排斥反应 Altuviiio：与 Sobi 合作的 A 型血友病药物 收到 Form 483 后，赛诺菲曾在今年 2 月和 4 月两次向 FDA 提交了回应。FDA 在警告信中承认，赛诺菲的回应针对每个 Form-483 意见提出了纠正措施，但认为这些回应未能解决工厂质量部门不符合现行生产标准的 "根本性失败"。二、FDA 指出的核心问题：质量部门监督失效 FDA 在警告信中指出，该工厂的问题暴露出一种 "模式"—— 质量部门未能行使适当的监督职责，包括对数据完整性实践的监督。 具体而言，FDA 列出了多项违规： 1.实验室记录不完整工厂的质量部门未能确保实验室记录包含所有必要测试的完整数据。例如，未记录多个非活性微粒超标测试的结果，以供审查和调查。 更严重的是，FDA 发现沃特福德工厂的实验室记录 "不完整"，因为质量控制人员使用不受控的 "审查清单"（Review Checklists）来非正式地记录实验室记录的审查情况，而这些清单随后被丢弃。 2.记录可追溯性不足FDA 还指出，记录的更新并不总是可追溯的，也无法归因于特定的工作人员。 3.批次差异调查不力FDA 批评该工厂未能适当调查生产批次的差异或失败，包括 "该批次是否已经分发" 这样的关键问题。 FDA 认为，这些问题共同表明，工厂的质量体系存在系统性缺陷，而非孤立的个别问题。三、赛诺菲回应：严肃对待，全力整改 针对 FDA 的警告信，赛诺菲发言人在接受 Fierce Pharma 采访时表示："患者安全和我们产品的质量是我们的最高优先级。" "我们极其严肃地对待 FDA 向沃特福德工厂发出的警告信，" 发言人继续说道，"我们正在采取立即行动，并致力于全面、有力且可持续地解决 FDA 提出的每一项意见。" 赛诺菲表示，计划与 FDA 密切合作以满足其要求。发言人同时强调，所有从爱尔兰工厂发布的产品 "都符合既定的质量和安全规范"。 关于供应影响，赛诺菲表示，目前 "预计不会对我们的药品供应能力产生影响"。四、背景：Genzyme 工厂并非首次 "踩雷" 值得注意的是，这已经不是赛诺菲旗下 Genzyme 工厂第一次收到 FDA 警告信了。 就在一年多前，赛诺菲 Genzyme 位于美国马萨诸塞州弗雷明汉的工厂也曾收到过 FDA 的警告信。那次的问题集中在生产错误调查不力、药物成分生产不一致等方面。 Genzyme 原本是一家专注于罕见病、肾病、癌症以及移植和免疫疾病的生物科技公司。赛诺菲于 2011 年以 200 多亿美元的价格收购了 Genzyme。在 2022 年赛诺菲的品牌重塑中，Genzyme 被更全面地整合进了赛诺菲的企业体系。 此次爱尔兰工厂再收警告信，无疑给赛诺菲的生产质量管控敲响了警钟。对于跨国药企而言，如何确保全球各地工厂的质量体系一致性，始终是一个巨大的挑战。 参考来源：https://www.fiercepharma.com/pharma/sanofi-unit-ireland-chided-fda-over-manufacturing-flubs-linked-altuviiio 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator. Sanofi’s long-held Genzyme unit has now received the more serious wrist slap of a warning letter from the FDA, after agency officials visited the Sanofi site in Waterford, Ireland, between Jan. 12 and Jan. 20 this year. The site inspection uncovered what the FDA has branded “significant” manufacturing violations tied to Sanofi’s Thymoglobulin (Anti-thymocyte Globulin [Rabbit]) product— indicated to prevent and treat acute rejection in kidney transplant patients—as well as its Sobi-partnered hemophilia A drug Altuviiio. In an emailed statement, a Sanofi spokesperson stressed to Fierce that “patient 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,” the spokesperson continued. “We are taking immediate actions and are committed to fully addressing each of the Agency’s observations, robustly and sustainably.” Following receipt of the Form 483 at the Ireland site earlier this year, Sanofi responded to the FDA’s concerns in February, again following up in April. The FDA conceded in its warning letter that Sanofi’s responses pointed to “corrective actions to address each individual Form-483 observation.” However, the agency argued that the reply still neglected to address the “underlying failure” of the site’s quality unit to meet current manufacturing standards. The FDA also suggested that several responses Sanofi proposed may be inadequate, with the crux of its argument suggesting that the site fumbles to “demonstrate a pattern in which your quality unit failed to exercise proper oversight, including oversight of your data integrity practices.” In the warning letter, the FDA noted that the Genzyme Ireland site’s quality unit didn’t make sure lab records included complete data from all necessary tests, failing to document multiple non-viable particulate excursion tests for review and investigation, among other missteps. The FDA further asserted that the Waterford facility’s laboratory records “were incomplete because quality control personnel used uncontrolled Review Checklists to unofficially document laboratory record reviews, which were subsequently discarded.” Record updates weren’t always traceable or attributable to a specific worker, either, the FDA pointed out. The agency also chided the site for failure to properly investigate manufacturing batch discrepancies or failures, including “whether or not the batch has already been distributed.” Sanofi plans to work in tandem with the FDA to meet its requirements, the company spokesperson told Fierce on Wednesday, adding that all products released from the Ireland site “meet established quality and safety specifications.” The company does “not anticipate any impact on our ability to supply medicines at this time,” per the spokesperson. The FDA reprimand comes more than a year after Sanofi's Genzyme unit received a separate warning letter at its facility in Framingham, Massachusetts, in that instance focused on subpar manufacturing error investigations and inconsistent drug ingredient production, among other problems. Sanofi acquired Genzyme way back in 2011, spending a little more than $20 billion for the company historically focused on inherited disorders, kidney diseases, cancer and transplant and immune diseases. The company was more holistically absorbed into the Sanofi corporate scheme during the French pharma’s branding overhaul in 2022.