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

Source: https://www.keypedia.com/records/483/mylan-inc-a-viatris-company/1744c642-c3c6-4602-b6c5-6684d02daadb

> FDA 483 for Mylan, Inc. A Viatris Company on December 12, 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: 2025-12-12
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Documents

- [483 - 2025-12-22](https://www.keypedia.com/records/483/mylan-inc-a-viatris-company/c874bf1c-0324-471a-a5ab-14f60501112a)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8