Viatris disclosed that its manufacturing facility in Indore, India, was issued a warning letter from the FDA, which banned 11 products that are produced at the site from being imported into the U.S. for distribution.
The severe action from the U.S. regulatory agency falls in the wake of an inspection conducted at the facility “earlier this year," the company said in a Dec. 23 statement. The plant produces oral finished-dose products.
Viatris, which is based in Pittsburgh and was formed back in 2020 with the merger of Mylan and Upjohn, didn’t disclose details of the inspection. As for the import alert, the company said the agency could make an exception for four (and possibly more) of the products due to drug shortage concerns.
The warning letter has yet to be posted to the FDA website.
“Following the substance of FDA’s original inspection observations, we immediately implemented a comprehensive remediation plan at the site,” the company said in the statement. “The necessary corrective and preventive actions are well underway, including but not limited to related personnel actions.”
The company said it will submit its official response to the FDA and that it doesn’t expect the regulatory action will impact its current fiscal guidance for 2024.
“We will incorporate potential future financial impact in our 2025 guidance ranges when we provide these in early 2025,” the company added.