Viatris announced on Monday that the U.S. Food and Drug Administration (FDA) has restricted imports of 11 products manufactured at its facility in Indore, Madhya Pradesh, after an inspection revealed violations of federal requirements.
The FDA issued a warning letter to the company regarding the facility, which produces oral finished doses such as tablets and capsules. While the specifics of the violations were not disclosed, the 11 affected products will be barred from entering the U.S. until the warning letter is resolved, Viatris said in a statement.
The company added that, to address potential shortages, the FDA has granted conditional exceptions for four products, with the possibility of additional exemptions based on further discussions. Viatris did not specify which products were impacted by the restrictions.
Viatris, formed through the merger of Mylan and Pfizer’s off-patent drug business, operates four manufacturing sites in India, producing tablets and capsules across various therapeutic categories, including antibacterials, diabetes treatments, and cardiovascular drugs.
The company stated that it has already implemented a remediation plan at the Indore facility and is taking necessary corrective and preventive actions. Independent third-party experts have also been engaged to support these efforts. Viatris confirmed that it will submit its response to the FDA’s warning letter and import alert within the required timeframes.
The company and the FDA did not immediately respond to Reuters’ requests for additional information. Viatris emphasized its commitment to addressing the FDA’s concerns and ensuring compliance with regulatory requirements.
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