Viatris Issues Statement Regarding Receipt Of Warning Letter And Import Alert For Indore, India Facility; The Import Alert Affects 11 Actively Distributed Products That Will No Longer Be Accepted Into The U.S. Until The Warning Letter Is Lifted
Viatris Issues Statement Regarding Receipt Of Warning Letter And Import Alert For Indore, India Facility; The Import Alert Affects 11 Actively Distributed Products That Will No Longer Be Accepted Into The U.S. Until The Warning Letter Is Lifted
We have been in regular communication with FDA during this process and will continue to work to ensure that the Agency is satisfied with the steps we have taken to resolve all the points raised. Our response to the Warning Letter and Import Alert will be submitted within the required time periods.Our plants around the world are regularly inspected by health authorities to ensure compliance with the various markets we serve. Following an inspection by the U.S. FDA at our oral finished dose manufacturing facility in Indore, India earlier this year, the Agency has issued a Warning Letter, and an Import Alert related to this facility.
我們在全球的工廠定期接受衛生部門的檢查，以確保符合我們所服務的各個市場的要求。今年早些時候，印度印多爾的口服成品製造設施接受了美國FDA的檢查，機構已對該設施發出了警告信，並發佈了進口警報。
The Import Alert affects 11 actively distributed products that will no longer be accepted into the U.S. until the Warning Letter is lifted. It makes exceptions, subject to certain conditions, for four products based on shortage concerns. There could be the potential for additional exceptions based on further discussions with the Agency.
進口警報影響11種活躍分銷的產品，直到警告信解除之前將不再被接受進入美國。基於短缺問題，對四種產品存在例外，受某些條件的限制。與機構的進一步討論可能帶來額外的例外。
Following the substance of FDA's original inspection observations, we immediately implemented a comprehensive remediation plan at the site. The necessary corrective and preventive actions are well underway, including but not limited to related personnel actions. Additionally, we have engaged independent third-party subject matter experts to support the remediation plan.
根據FDA最初檢查觀察的實質內容，我們立即在現場實施了一項全面的整改計劃。必要的糾正和預防措施正在順利進行，包括但不限於相關的人事行動。此外，我們已聘請獨立的第三方主題專家來支持整改計劃。
We have been in regular communication with FDA during this process and will continue to work to ensure that the Agency is satisfied with the steps we have taken to resolve all the points raised. Our response to the Warning Letter and Import Alert will be submitted within the required time periods.
在這個過程中，我們與FDA保持定期溝通，並將繼續努力確保該機構對我們爲解決所有提出的問題所採取的措施感到滿意。我們對警告信和進口警報的回應將在規定的時間內提交。
At this time, we do not anticipate these actions impacting our current 2024 financial guidance ranges. We will incorporate potential future financial impact in our 2025 guidance ranges when we provide these in early 2025.
目前，我們不預計這些行動會影響我們2024年的財務指導範圍。我們將在2025年初提供這些指導時，在我們的2025財務指導範圍中納入潛在的未來財務影響。
We take very seriously our continued and comprehensive oversight of our entire manufacturing network. Patient safety remains our primary and unwavering focus. We will work closely with our customers to mitigate any possible supply disruptions and meet the needs of the patients we serve.
我們非常重視對整個製造網絡的持續和全面的監督。患者安全始終是我們首要且堅定不移的關注點。我們將與客戶密切合作，減輕任何可能的供應中斷，滿足我們服務的患者的需求。
譯文內容由第三人軟體翻譯。