FDA 483 - Mylan, Inc. A Viatris Company - December 22, 2025

Mylan, Inc. A Viatris Company, located in Canonsburg, PA, was inspected by the FDA from December 8-22, 2025, as a sponsor of clinical studies. The inspection revealed a significant failure to provide adequate written Investigational New Drug (IND) safety reports. This included the omission of multiple Suspected Unexpected Serious Adverse Reactions (SUSARs), Serious Adverse Events (SAEs), and information on subjects withdrawn from a clinical study due to SAEs.