Viatris confirms receipt of warning letter, import alert for India facility

Viatris (VTRS) issued the following statement: “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. 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. 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. 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. 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. 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.”