FDA Restricts Import of Certain Viatris Products Due to Facility Violations

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

After conducting an inspection, the FDA issued a warning letter to the pharmaceutical company, stating that products would not be accepted into the U.S. until the issues raised in the warning letter are resolved.

Viatris disclosed that the FDA granted conditional exemptions for four products due to potential shortage concerns. In response to the FDA's warning, Viatris has swiftly implemented an improvement plan at the facility. The company noted that necessary corrective and preventive measures are currently underway and has engaged the assistance of independent third-party experts to support this improvement plan.

In its statement, the company emphasized that it has maintained ongoing communication with the FDA throughout this process. Viatris stated that it intends to continue working to ensure the agency is satisfied with the steps taken to address all points raised in the warning letter.

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