Viatris (VTRS) said Monday that the US Food and Drug Administration has issued a warning letter and an import alert to its oral finished dose manufacturing facility in India, following an inspection earlier this year.
The import alert impacts 11 products, which will not be accepted in the US until the FDA lifts the warning letter, Viatris said.
Viatris said it has implemented a "comprehensive" remediation plan, including corrective and preventive actions, and continues to work with the FDA to address the issues raised.
The company does not anticipate these actions will affect its 2024 financial guidance and plans to update its 2025 financial guidance accordingly, Viatris said.
Viatris shares fell 0.6% in recent trading.
Price: 12.44, Change: -0.08, Percent Change: -0.62
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