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.