# FDA 483 - Viatris Inc. - November 18, 2016

Source: https://www.globalkeysolutions.net/records/483/viatris-inc/afa3589b-bae0-4641-aa0e-5f252d238128

> FDA 483 for Viatris Inc. on November 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viatris Inc.
- Inspection Date: 2016-11-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: During an inspection from November 7-18, 2016, Mylan Pharmaceuticals Inc. in Morgantown, WV, was cited for significant deficiencies across its quality control and R&D operations. The firm failed to maintain adequate laboratory controls, including retesting without investigation and incomplete data records, and used non-validated analytical methods. Furthermore, Mylan did not thoroughly investigate unexplained discrepancies, such as recurring OOS results and manufacturing issues like thick or friable tablets, and exhibited deficient complaint handling practices.

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e