FDA restricts import of certain Viatris products due to plant violations

Investing.com -- Viatris announced on Monday that the U.S. Food and Drug Administration (FDA) has imposed restrictions on the import of 11 products manufactured at its drug production facility in India. This decision follows the FDA's warning about violations of federal requirements at the plant.

The FDA issued a warning letter to the pharmaceutical company after conducting an inspection at the facility. The agency stated that the products will not be accepted into the U.S. until the warning letter is resolved.

Viatris revealed that the FDA had made conditional exceptions for four products due to concerns about potential shortages.

In response to the FDA's warning, Viatris promptly put a remediation plan in place at the facility. The company stated that necessary corrective and preventive measures are already in progress. To support this remediation plan, Viatris has also enlisted the help of independent third-party experts.

In a statement, the company emphasized its ongoing communication with the FDA throughout this process. Viatris plans to continue working to ensure the agency is content with the steps taken to address all the points raised in the warning letter.

Neither Viatris nor the FDA have yet responded to requests for comment.

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Source: Investing.com