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