(Reuters) -Viatris said on Monday the U.S. Food and Drug Administration had restricted the importation of 11 products made at its drug manufacturing facility in India after warning about violations of federal requirements at the plant.
The FDA issued a warning letter to the drugmaker after an inspection at the facility and said the products will no longer be accepted into the U.S. until the warning letter is lifted.
The agency made conditional exceptions for four products based on shortage concerns, Viatris said.
The company immediately implemented a remediation plan at the site and said necessary corrective and preventive actions were well underway.
It also engaged independent third-party 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,” the company said in a statement.
Viatris and the FDA did not immediately respond to Reuters requests for comment.
(Reporting by Sneha S K; Editing by Shilpi Majumdar and Devika Syamnath)
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