FDA hits Viatris with warning letter, restricts US imports for violations at India plant
Generic drug company Viatris announced that the FDA has restricted the importation of 11 “actively distributed” products made at its drug manufacturing facility in Indore, India, following undisclosed violations at the plant.
The regulator slapped Viatris with a warning letter and an import alert, banning the 11 products from entry into the U.S. until the warning letter is lifted.
“Following the substance of FDA’s original inspection observations, we immediately implemented a comprehensive remediation plan at the site. The necessary corrective and preventive actions are well underway, including but not limited to related personnel actions,” Viatris said in a statement.
The company said it has also “engaged independent third-party subject matter experts to support the remediation plan.”
Viatris does not expect the FDA’s actions will impact its current 2024 financial guidance ranges. However, the company said it “will incorporate potential future financial impact” in 2025 guidance ranges slated for early next year.
“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,” according to Viatris, while adding that its response to the regulator’s warning letter and import alert “will be submitted within the required time periods.”
More than half of manufacturers supplying the U.S. drug market are located overseas — mainly in China and India — according to the U.S. Government Accountability Office (GAO). In February 2024, the FDA said it planned to increase inspections of Indian manufacturing facilities this year amid growing quality and supply concerns.
However, that same month, GAO Healthcare Director Mary Denigan-Macauley testified before a congressional subcommittee that the FDA continues to face “persistent challenges” overseeing foreign drug manufacturing.
The chairs of the House Energy and Commerce Committee and two subcommittees sent a letter over the summer to FDA Commissioner Robert Califf pressing the agency for more information regarding “large variations” in its foreign drug inspection program.
The lawmakers noted “widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India.”