Viatris Inc. announced that it has received a warning letter and an Import Alert from the U.S. Food and Drug Administration (FDA). These actions follow an inspection at the company's oral finished dose manufacturing facility located in Indore, India, earlier this year.
The Import Alert specifically affects 11 actively distributed products. These products will no longer be accepted into the U.S. market until the warning letter is officially lifted by the FDA.
This regulatory action is a significant setback for Viatris, as it directly impacts its supply chain and ability to serve the U.S. market for certain products. The warning letter indicates manufacturing quality control issues that require substantial remediation efforts by the company.
The import restrictions are expected to have a material negative financial impact on Viatris's operations and revenue, particularly within its U.S. generics business. The company will need to prioritize and execute a comprehensive remediation plan to address the FDA's concerns and restore full operational capacity for U.S. supply.
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