FDA 483 - Mylan, Inc. A Viatris Company - December 12, 2025

Mylan Inc., A Viatris Company, located in Canonsburg, PA, was inspected regarding a clinical study. The inspection revealed that the firm failed to include required safety information, specifically SUSARS, SAEs, and details of subject withdrawals, in their IND annual reports and amendments. This indicates a significant deficiency in their clinical trial reporting practices.