FDA 483 - Viatris Inc. - July 25, 2019

An FDA inspection of Mylan Pharmaceuticals Inc. in Morgantown, WV, revealed significant and recurring deficiencies across its human drug manufacturing operations. Issues included inadequate investigations into out-of-specification results and stability failures, widespread cleaning validation and equipment maintenance problems, and a failure of the Quality Unit to follow established procedures and ensure timely closure of critical events. These observations indicate systemic control and quality assurance breakdowns impacting multiple drug products.