FDA Imposes Import Restrictions on 11 Viatris Products from Indian Facility Due to Regulatory Violations

Import Restrictions:
The US FDA has restricted imports of 11 products manufactured at Viatris' facility in Indore, India, due to violations of federal requirements found during an inspection14.

Warning Letter:
The FDA issued a warning letter to Viatris related to its drug manufacturing facility in Indore, which led to the import restrictions14.

Conditional Exceptions:
Due to shortage concerns, the FDA has made conditional exceptions for four products, allowing them to be imported despite the restrictions14.

Remediation Plan:
Viatris has implemented a comprehensive remediation plan at the site, including corrective and preventive actions, and has engaged independent third-party experts to support the plan12.

Impact on Financial Guidance:
Viatris does not expect the FDA's actions to impact its current 2024 financial guidance ranges but will incorporate potential future financial impacts in its 2025 guidance ranges2.

Regulatory Scrutiny:
The import restrictions highlight the importance of compliance with manufacturing regulations and the FDA's increased scrutiny of foreign drug manufacturing facilities, particularly in India and China25.

Sources:

1. https://timesofindia.indiatimes.com/business/india-business/us-fda-restricts-imports-of-some-viatris-drugs-made-at-india-facility/articleshow/116604643.cms

2. https://www.pharmamanufacturing.com/industry-news/news/55251465/fda-hits-viatris-with-warning-letter-restricts-us-imports-for-violations-at-india-plant

4. https://www.business-standard.com/companies/news/usfda-restricts-imports-of-certain-viatris-drugs-made-at-india-facility-124122300984_1.html

5. https://www.bajajbroking.in/blog/us-fda-restricts-imports-of-viatris-drugs-manufactured-at-indian-facility