FDA 483 - Viatris Inc. - May 26, 2022

Mylan Pharmaceuticals Inc. in Morgantown, WV, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality control unit, including untimely annual product reviews and inadequate stability testing verification for contract manufactured drugs. Additionally, the firm failed to submit a timely NDA-Field Alert Report, had prolonged complaint investigations, and maintained a stability program with unreliable test methods.