FDA 483 - Viatris Inc. - November 18, 2016

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.