# FDA 483 - Viatris Inc. - August 15, 2019

Source: https://www.keypedia.com/records/483/viatris-inc/9e200adb-c8fe-45a3-bf9b-b1fdcc0a6b7d

> FDA 483 for Viatris Inc. on August 15, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Viatris Inc.
- Inspection Date: 2019-08-15
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Mylan Pharmaceuticals Inc. in Morgantown, WV, revealed a significant issue with complaint file maintenance. Specifically, the firm failed to adequately maintain Adverse Event Reports as complaint files and did not perform sufficient investigations for nine out of ten reviewed Adverse Event Reports. This indicates a deficiency in the firm's complaint handling procedures.

## Related Documents

- [483 - 2016-11-18](https://www.keypedia.com/records/483/viatris-inc/afa3589b-bae0-4641-aa0e-5f252d238128)
- [483 - 2018-04-12](https://www.keypedia.com/records/483/viatris-inc/24a2a7cc-647e-427c-9f53-a9a19e40ec12)
- [483 - 2019-07-25](https://www.keypedia.com/records/483/viatris-inc/5ad9b2c3-4f0d-434b-9011-3fcc0d10111e)
- [483 - 2022-05-26](https://www.keypedia.com/records/483/viatris-inc/8ba662c8-1553-4929-bc10-4fe7831bbf9c)
- [WARNING_LETTER - 2024-06-26](https://www.keypedia.com/records/warning_letter/viatris-inc/486d0c63-dd02-4bd9-a54c-75405be98540)

## Related Officers

- [Katelyn A. Staub-Zamperini](https://www.keypedia.com/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.keypedia.com/companies/viatris-inc/e65d242e-4279-4e07-992f-5f241792c2cf

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