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

Source: https://www.globalkeysolutions.net/records/483/mylan-inc-a-viatris-company/c874bf1c-0324-471a-a5ab-14f60501112a

> FDA 483 for Mylan, Inc. A Viatris Company on December 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan, Inc. A Viatris Company
- Inspection Date: 2025-12-22
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: 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Suspected Unexpected Serious Adverse Reactions (SUSARs), Serious Adverse Events (SAEs), and information on subjects withdrawn from a clinical study due to SAEs.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/brittany-l-carpenter/600db4d0-0b6b-435f-b511-2ca10f292d5d)

Company: https://www.globalkeysolutions.net/companies/mylan-inc-a-viatris-company/fd18d0b8-0038-4c4d-b3d5-545c9077eed5

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64