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US FDA restricts imports of some Viatris products made in India
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US FDA restricts imports of some Viatris products made in India
Dec 23, 2024 5:42 AM

Dec 23 (Reuters) - Viatris ( VTRS ) 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 ( VTRS ) 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 ( VTRS ) and the FDA did not immediately respond to

Reuters requests for comment.

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