# FDA 483 - Viatris Inc. - May 26, 2022

Source: https://www.globalkeysolutions.net/records/483/viatris-inc/8ba662c8-1553-4929-bc10-4fe7831bbf9c

> FDA 483 for Viatris Inc. on May 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viatris Inc.
- Inspection Date: 2022-05-26
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Mylan Pharmaceuticals Inc. in Morgantown, WV, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality control unit, including untimely annual product reviews and inadequate stability testing verification for contract manufactured drugs. Additionally, the firm failed to submit a timely NDA-Field Alert Report, had prolonged complaint investigations, and maintained a stability program with unreliable test methods.

## Related Documents

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- [WARNING_LETTER - 2024-06-26](https://www.globalkeysolutions.net/records/warning_letter/viatris-inc/486d0c63-dd02-4bd9-a54c-75405be98540)

## Related Officers

- [Janat A Rajah](https://www.globalkeysolutions.net/people/janat-a-rajah/8945158a-c2e0-40e9-a140-46aa802d33f8)
- [Johnna L. Bleem](https://www.globalkeysolutions.net/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)
- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)

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

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