(Reuters) -Viatris said on Monday the U.S. Food and Drug Administration has restricted imports of 11 products made at the drugmaker’s facility in India after the regulator’s inspection found it had violated federal requirements.
The FDA has issued a warning letter to Viatris related to its drug manufacturing facility in Indore in the central Indian state of Madhya Pradesh, the company said, without disclosing the specifics of the warning.
The 11 products will no longer be accepted into the U.S. until the warning letter is lifted, Viatris said in a statement.
It was not immediately clear which products were affected. The drugmaker said the facility makes oral finished doses such as tablets and capsules.
Due to shortage concerns, the agency has made conditional exceptions for four products, Viatris said. There could be potential for additional exceptions based on further discussions with the FDA.
Viatris was formed through the merger of Mylan and Pfizer’s off-patent drug business.
It operates four sites in India that manufacture tablets and capsules for a wide range of therapeutic categories such as antibacterials, diabetes drugs and cardiovascular therapies, according to its website.
Viatris said its response to the warning letter and import alert would be submitted within the required time periods.
The company said it had immediately implemented a remediation plan at the site and that necessary corrective and preventive actions were underway.
It also engaged independent third-party experts to support the remediation plan.
Viatris and the FDA did not immediately respond to Reuters’ requests seeking additional details.
(Reporting by Sneha S K; Editing by Shilpi Majumdar and Devika Syamnath)
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