FDA Restricts Imports Of Drug Products Made In Indore For Violations

Photo: Viatris

NEW DELHI, (Reuters) -The drug company Viatris announced on December 23 that the U.S. Food and Drug Administration (FDA) has restricted imports of 11 products made at its facility in Indore, following an inspection that revealed violations of federal regulations.

The FDA issued a warning letter to Viatris related to the facility, although the specifics of the violations were not disclosed.

As a result of the FDA’s actions, the 11 affected products will not be accepted into the U.S. until the warning letter is resolved. While the specific products were not named, Viatris confirmed that the facility produces oral finished doses, including tablets and capsules.

In light of potential shortages, the FDA has made conditional exceptions for four products, with the possibility of more exceptions following further discussions with the agency.

Viatris, formed through the merger of Mylan and Pfizer’s off-patent drug business, operates four manufacturing sites in India that produce a wide range of therapeutic products, including antibacterials, diabetes medications, and cardiovascular treatments.

The company stated it has already initiated a remediation plan and is working with independent third-party experts to address the issues. Viatris also confirmed it would respond to the warning letter and import alert within the required timeframes.

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