483
Viatris Inc.FDA 483 - Viatris Inc. - November 18, 2016
Record Details
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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ID · afa3589b-bae0-4641-aa0e-5f252d238128