On December 23, the pharmaceutical company Viatris announced that the U.S. Food and Drug Administration (FDA) has imposed restrictions on the importation of 11 products manufactured at its Indore facility, following an inspection that identified breaches of federal regulations. Although the FDA issued a warning letter concerning the facility, the details of the violations have not been made public. Consequently, the 11 products in question will be barred from entering the U.S. until the issues raised in the warning letter are adequately addressed. While the specific products have not been identified, Viatris has confirmed that the facility is responsible for producing oral finished dosage forms, such as tablets and capsules.
To mitigate potential shortages, the FDA has granted conditional exceptions for four products, with the possibility of additional exceptions pending further discussions with the agency. Viatris, which was established through the merger of Mylan and Pfizer’s off-patent drug division, operates four manufacturing sites in India that produce a diverse array of therapeutic products, including antibacterials, diabetes treatments, and cardiovascular medications.The company has indicated that it has already begun implementing a remediation plan and is collaborating with independent third-party experts to rectify the identified issues. Furthermore, Viatris has confirmed its commitment to responding to the warning letter and import alert within the stipulated timeframes.
