483
Viatris Inc.Viatris Inc. – FDA 483, Aug 15, 2019
Record Details
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.
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ID · 9e200adb-c8fe-45a3-bf9b-b1fdcc0a6b7d
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