# FDA 483 - Viatris Inc. - July 25, 2019

Source: https://www.keypedia.com/records/483/viatris-inc/5ad9b2c3-4f0d-434b-9011-3fcc0d10111e

> FDA 483 for Viatris Inc. on July 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viatris Inc.
- Inspection Date: 2019-07-25
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Mylan Pharmaceuticals Inc. in Morgantown, WV, revealed significant and recurring deficiencies across its human drug manufacturing operations. Issues included inadequate investigations into out-of-specification results and stability failures, widespread cleaning validation and equipment maintenance problems, and a failure of the Quality Unit to follow established procedures and ensure timely closure of critical events. These observations indicate systemic control and quality assurance breakdowns impacting multiple drug products.

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

## Related Officers

- [Susan T Arista](https://www.keypedia.com/people/susan-t-arista/11d13ee0-8a35-4b5f-864e-f37b952c010d)
- [John P. Mittler](https://www.keypedia.com/people/john-p-mittler/40d166eb-2825-4f9b-9aef-a03936cf4e8c)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94