Following an inspection that revealed violations of federal manufacturing requirements, the U.S. Food and Drug Administration (FDA) has imposed restrictions on imports of 11 products manufactured at Viatris’ facility in Indore, India. Viatris announced the decision on Monday, following a warning letter issued by the FDA regarding the site’s compliance issues.
Viatris has not disclosed specific details about the FDA’s findings but confirmed that the affected products will not be allowed entry into the U.S. market until the warning letter is resolved. The facility, located in the central Indian state of Madhya Pradesh, specializes in producing oral finished doses, including tablets and capsules.
The FDA has granted conditional exceptions for four of the affected products to address potential drug shortages. Viatris noted that additional exceptions could be negotiated based on ongoing discussions with the agency.
Formed through the merger of Mylan and Pfizer’s off-patent drug business, Viatris operates four manufacturing sites in India. It produces a diverse range of medications, including antibacterials, diabetes treatments, and cardiovascular therapies.
In response to the FDA’s actions, Viatris has committed to submitting a comprehensive reply to the warning letter and import alert within the required timeframe. The company has also implemented a remediation plan at the Indore facility, focusing on corrective and preventive measures to address compliance issues. Independent third-party experts have been engaged to support these efforts.
Neither Viatris nor the FDA has provided additional details at this time. The situation underscores the critical importance of adherence to regulatory standards in pharmaceutical manufacturing to ensure product safety and efficacy.
